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RecruitingNCT05305313Updated Apr 27, 2026

Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System

A Phase 4 interventional study of Propofol and Propofol in Obesity, Morbid, Anesthesia and Propofol, sponsored by Sir Ganga Ram Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Sir Ganga Ram Hospital · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The pharmacokinetic profile of various drugs is altered in obese patients especially those administered by the intravenous route. Propofol is the commonly used intravenous anesthetic agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen. A major concern with propofol dosing based on total body weight (TBW) in obese patients is disproportionate drug administration leading to undue drug accumulation in body with a potential to overdosing, delayed recovery from anaesthesia, and adverse hemodynamic outcome. Studies on propofol dosing based on various weight scalars have recommended that lean body weight (LBW) should be used for calculating bolus dose during anaesthesia induction and TBW or adjusted body weight (ABW) for arriving at an infusion dose required for maintenance of anesthesia. Although propofol delivery based on dose calculated by TBW has been well researched the evidence for propofol delivery based on dose calculated by ABW is lacking.

Recent advance in the delivery of propofol has been the development of computer controlled anaesthesia delivery systems. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration. One such indigenously developed computer controlled anaesthesia delivery system is the closed loop anesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anesthetized patients with the help of a BIS- monitor, which is continuously fed into an automated drug infusion pump. The infusion pump then accordingly delivers the anesthetic drug to the patients based on pharmacodynamic requirements. The investigators plan to evaluate the propofol maintenance dose requirement based on TBW versus ABW using CLADS for propofol delivery.

Read the detailed description

Propofol is the most used intravenous agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen.

In the morbidly obese, various factors, such as, increased body fat content, lean body weight, cardiac output, total blood volume, and alterations in regional blood flow; which adversely/unpredictably affect the volume of distribution, clearance and elimination of intravenous anesthetic drugs, thereby making administration of TIVA difficult to control.

A major concern with propofol dosing based on total body weight (TBW) in the obese patients is disproportionate drug administration leading to undue drug accumulation in body with potential overdosing, delayed recovery from anaesthesia, and adverse hemodynamic outcome. Studies on propofol dose regimen for TIVA recommended that LBW should be used for calculating bolus dose during induction of anaesthesia and TBW or ABW for arriving at a infusion dose required for maintenance of anaesthesia.

Propofol requirement for induction of anaesthesia is based on LBW is especially relevant for the morbidly obese patients as because their surplus fat mass increases volume of distribution of propofol, which, in the face of decreased blood flow to adipose tissue; imposes the burden of potential drug accumulation. This may result in increased drug delivery to non-adipose tissue during induction of anaesthesia and possibly leading to undesirable rarefaction of depth-of-anaesthesia and attendant adverse haemodynamic effects.

Conversely, during the maintenance phase of propofol TIVA, the volume of distribution and clearance of propofol increases and correlates linearly with TBW. In this respect, controlling propofol delivery in the morbidly obese with Eleveld allometric PK model, which utilizes TBW as weight parameter; has been found to be superior to other models that employs other weight dosing scalars.

The use of ABW in Schnider and Marsh model takes into consideration drug distribution to lean tissues as well as a proportion to the body fat weight, thus accounting for lipid solubility dynamics of propofol. ABW is calculated by adding 40% excess fat weight (FW) to IBW.

In obese patients propofol delivery using the Eleveld allometric PK model by incorporating TBW has been found to be superior to other models using other dosing scalars.

Target-controlled infusion (TCI) forms the core of standard-of-care method used for administration of propofol TIVA. TCI system typically includes a microprocessor-controlled syringe pump that is designed to achieve a defined plasma concentration of the drug based on patient response and multi-compartment pharmacokinetic (PK) model.

While TCI systems are designed to deliver propofol at a rate based on a predetermined plasma concentration, they do not take into consideration patient's pharmacodynamic profile. Hence, it is difficult to determine whether the target plasma concentration achieved has produced adequate anaesthesia depth. In the absence of reliable depth of anaesthesia monitors, during the maintenance phase of propofol TIVA, the desired plasma concentration achieved may either result in intraoperative awareness due to under-dosing or delayed recovery from anaesthesia because of over-dosing.

Currently, an array of research on automated propofol delivery using computer-controlled closed loop anaesthesia delivery systems which deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS); have amply exhibited that these systems deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration.

Liu et al used a BIS-guided dual loop anaesthesia delivery system to determine requirement of propofol and remifenatnil in the obese versus lean patients. The propofol delivery was controlled by a closed loop set through TCI pump. Propofol was delivered with dose calculation by TBW and based on the Schnider model. The propofol dosage delivered as per TBW in real-time was analyzed post hoc on a IBW scale. The propofol requirements for induction and maintenance based on TBW was equivalent both in obese and lean patients.

CLADS is a BIS-guided automated closed-loop anaesthesia delivery system developed by Puri, which delivers propofol using a non-TCI infusion pump. This system uses a control algorithm that is based on the relationship between diverse rates of propofol infusion and BIS variable. CLADS regulates the propofol infusion rate to maintain a predetermined BIS target (BIS=50) and is independent of plasma propofol concentration status. CLADS is uniquely versatile in that it can calculate propofol dosage delivered both on basis of TBW or IBW.

Whereas, in a study comparing CLADS administered propofol versus desflurane-GA in morbid obese patients undergoing bariatric surgery (unpublished data) the propofol maintenance dosage based on ABW was 5.5 + 1.3 mg kg-1 h-1; Liu et al reported a median propofol consumption of 5.2 [4.1, 6] mg kg-1 h-1 with their dual-loop closed loop anaesthesia delivery system that also utilized TBW based administration of propofol and remifentanil. In both the study, BIS was used as an input control actuator to close the feedback loop joining the patient, the delivery system, and the infusion flow system.

Although maintenance of propofol TIVA based on TBW is well established, the dosing schedule based on ABW is not well explored. Since the ABW takes into consideration a certain percentage of FW in addition to IBW and not the complete FW as in TBW, we hypothesize that propofol dosing using ABW will result in lower propofol requirement as compared to TBW for maintaining equivalent anesthetic depth. Since CLADS gives an objective assessment of propofol dose delivered and anaesthesia depth consistency, this randomized study aim to compare the maintenance requirements of propofol in obese patients given propofol dosing based on TBW versus ABW

02

Conditions studied

  • Obesity, Morbid
  • Anesthesia
  • Propofol

Browse trials for

03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 46 is below the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Sir Ganga Ram Hospital is the lead sponsor of 30 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. II/III
  2. laparoscopic and non-laparoscopic surgery of more than 60-minutes duration
  3. > 35kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
  2. Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, )
  3. Hepato-renal insufficiency
  4. Uncontrolled diabetes mellitus
  5. Known allergy/ to study drug
  6. Pulmonary dysfunction (restrictive /obstructive lung disease)
  7. Acute/chronic drug dependence/substance abuse
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    Total Body Weight group

    Anesthesia will be induced and maintained with Propofol administered by CLADS which will be set to deliver Propofol according to total body weight (TBW). A BIS-value of 50 will be used as the target for induction and maintaenance of anesthesia.

    Drug: Propofol

  • Active comparator
    Adjusted Body Weight group

    Anesthesia will be induced and maintained with Propofol administered by CLADS which will be set to deliver Propofol according to adjusted body weight (ABW). A BIS-value of 50 will be used as the target for induction and maintenance of anesthesia.

    Drug: Propofol

Interventions

  • Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.

  • Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.

06

What researchers measure

Primary outcomes

  1. Propofol Maintenance Dose (mg/kg/hour)

    Propofol required for maintenance of anaesthesia based on total body weight versus adjusted body weight

    Time frame: From start of anesthesia till 5- minutes post skin closure

Secondary outcomes

  1. Anaesthesia Depth consistency

    Percentage of the total valid CLADS time during which the BIS remained + 10% of the target BIS value of 50.

    Time frame: From start of anesthesia till 5- minutes post skin closure

  2. Performance characteristic of propofol delivery system

    It will be determined using the Varvel criteria parameter :median performance error (MDPE). This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number

    Time frame: From start of anesthesia till 5- minutes post skin closure

  3. Performance characteristic of propofol delivery system

    It will be determined using the Varvel criteria parameter: median absolute performance error (MDAPE).This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.

    Time frame: From start of anesthesia till 5- minutes post skin closure

  4. Performance characteristic of propofol delivery system

    It will be determined using the Varvel criteria parameter: wobble. This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.

    Time frame: From start of anesthesia till 5- minutes post skin closure

  5. Performance characteristic of propofol delivery system

    It will be determined using the Varvel criteria parameter: global score. It is calculated using the formula Median absolute performance error + wobble / percentage of the anesthesia time during which the BIS remained +/- 10 of the target BIS of 50. This parameter have no unit of measurement. Its just a abstract number.

    Time frame: From start of anesthesia till 5- minutes post skin closure

  6. Intra-operative heart Rate (beats per minute)

    Comparison of intra-operative heart rate between the study arms will be done

    Time frame: From beginning of anaesthesia till 10 hours intraoperatively

  7. Intra-operative systolic , diastolic, and mean blood pressure (mmHg)

    Comparison of intra-operative blood pressure- systolic, diastolic, and mean blood pressure between the study arms will be done

    Time frame: From beginning of anaesthesia till 10 hours intraoperatively

  8. Early recovery from anaesthesia

    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

    Time frame: From beginning of anaesthesia till 30-minutes postoperatively

  9. Early recovery from anaesthesia

    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

    Time frame: From beginning of anaesthesia till 30-minutes postoperatively

  10. Postoperative sedation

    Will be assessed using Modified Observer's assessment of alertness/sedation scale. The scale has a maximum value of '5', which refers to a fully awake patient and a minimum value of '0' which refers to a deeply sedated patient.

    Time frame: From end of anaesthesia till 24-hours postoperatively

  11. Intraoperative awareness

    Will be assessed using modified brice questionnaire. The questionnaire has a set of '5' questions, if answer to any of the question is in affirmative then it is suggestive of intraoperative awareness

    Time frame: From the end of anaesthesia till 48-hours, postoperatively

07

Study locations

1 of 1 sites recruiting
  • Nitin Sethi
    New Delhi, National Capital Territory of Delhi 110060, India
    Recruiting
    • Nitin Sethi, DNB · Contactnitinsethi77@yahoo.co.in · 009142252523
    • Amitabh Dutta, MD, PGDHR · Contact
    • Nitin Sethi, DNB · Principal investigator
    • Amitabh Dutta, MD, PGDHR · Principal investigator
    • Goverdhan D Puri, MD, PhD · Principal investigator
    • Jayashree Sood, MD, FFRCA, PGDHHM, FICA · Sub investigator
    • Anil Jain, MD, FICA · Sub investigator
    • Prabhat K Choudhary, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Nov 2027, 66 months after the start.

Of 28 phase 4 interventional studies under Obesity, Morbid, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 66 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2022
First posted
Mar 31, 2022
StartActual
Apr 19, 2022
Primary completionEst.
Nov 4, 2027
CompletionEst.
Nov 10, 2027
Last update
Apr 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05305313
Lead sponsor
Sir Ganga Ram Hospital
Responsible party
Nitin Sethi, DNB (Principal Investigator, Sir Ganga Ram Hospital) — Principal investigator
First posted
Mar 31, 2022
Start date
Apr 19, 2022
Primary completion
Nov 4, 2027 (estimated)
Completion
Nov 10, 2027 (estimated)
Last update
Apr 27, 2026

Study contacts

Nitin Sethi, DNB
Contact
nitinsethi77@yahoo.co.in
+919717494498
Amitabh Dutta, MD, PGDHR
Contact
duttaamitabh@yahoo.co.in
00919810873804
Goverdhan D Puri, MD, PhD
study director · Post Graduate Institute of Medical Education & Research, Chandigarh, India
Jayashree Sood, MD, FFRCA, PGDHHM, FICA
study chair · Sir Ganga Ram Hospital, New Delhi, INDIA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Propofol

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