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Status unknownNCT05777135Updated Apr 5, 2023

Ringer Lactate Preloading on Induction Dose Requirement of Propofol

A Phase 4 interventional study of Ringer Lactate prior to surgery and Propofol in Anesthesia and Ringer's Lactate, sponsored by National Medical College Birgunj. Status unknown at 1 site in Nepal. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by National Medical College Birgunj · Phase 4, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

  • To compare the effect (heart rate and mean arterial pressure) of Ringer Lactate preloading and without preloading on induction dose requirement of Propofol.
  • The Propofol requirement for induction dose with respect to loss of eyelash reflex in Ringer Lactate preloaded versus control group.
Read the detailed description
  1. From the operation list, patients that meet the Inclusion criteria will be selected. (n=60)
  2. Patients will be allocated into two participant groups. Group I and Group II respectively using Simple random sampling technique by Ballot method. Ballot method is to keep the list of patients that meet the inclusion criteria in two ballot box mentioning name and groups and do the lottery based selection for both groups and Patient code will be given.

  3. Group I (n = 30) Preloading with Ringer Lactate 30 ml/kg over 30 mins prior to surgery will be done and Propofol dose (2mg / kg ) requirement for induction of anaesthesia will be noted.

    Group II (n = 30) No Preloading will be done and Propofol dose (2mg / kg) requirement for induction of anaesthesia will be noted.

  4. Then, investigators will visualize for loss of eyelash reflex in both groups.
  5. The hemodynamic response (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) to intubation between the two participant groups will be noted. The total Propofol requirement for induction in Ringer Lactate preloaded versus control group will be recorded.
  6. Drug administration and parameters recording will be done by the anaesthesiologist / under supervision
02

Conditions studied

  • Anesthesia
  • Ringer's Lactate
03

In context

Lead sponsor

National Medical College Birgunj is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients scheduled for elective surgeries
  2. American Society of Anaesthesiologists (ASA) class I patients
  3. Age between 18-45 years
  4. Any surgery under general anaesthesia requiring endotracheal intubation
  5. Body mass index (BMI) -18.5 - 24.9
  6. Those providing written consent

Exclusion criteria

Exclusion Criteria:

  1. Emergency surgery
  2. Patients with multiple injuries, pregnancy
  3. Airway Mallampati grade II, III and IV
  4. Allergy to Ringer Lactate and Propofol.
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group I (Preloading with Ringer Lactate)

    Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted

    Drug: Ringer Lactate prior to surgery and Propofol

  • No intervention
    Group II (No preloading)

    No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted

Interventions

  • DrugRinger Lactate prior to surgery and Propofol

    Ringer Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted

    Also known as: Ringer Lactate group

06

What researchers measure

Primary outcomes

  1. Propofol dose Required (mg)

    Propofol dose (mg) with aspect to weight (kg)

    Time frame: Standard dosing in Operation

  2. Total Propofol dose given (mg)

    Propofol dose (mg)

    Time frame: Visualization of loss of eyelash reflex

  3. Loss of eyelash reflex (seconds)

    Visualization of loss of eyelash reflex (seconds)

    Time frame: Propofol given till loss of eyelash reflex

Secondary outcomes

  1. Units of Measure (e.g., weight and height)

    Weight in kilograms, height in meters ( weight and height will be combined to report BMI in kg/m²).

    Time frame: Preanaesthetic checkup, Day 1

  2. Heart rate (beats / minute): After IV Propofol

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Immediately After IV Propofol

  3. Heart rate (beats / minute): Baseline before IV fluid infusion

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Base line Before IV fluid infusion

  4. Heart rate (beats / minute): At intubation (0 minute)

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: At intubation (0 minute)

  5. Heart rate (beats / minute): Post intubation (1 minute)

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Post intubation (1 minute)

  6. Heart rate (beats / minute): Post intubation (3 minute)

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Post intubation (3 minute)

  7. Heart rate (beats / minute): Post intubation (5 minute)

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Post intubation (5 minute)

  8. Heart rate (beats / minute): Post intubation (10 minute)

    Heart rate (beats / minute) will be measured with pulse oxymeter

    Time frame: Post intubation (10 minute)

  9. Systolic blood pressure (mm Hg): Baseline before IV fluid infusion

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Baseline before IV fluid infusion

  10. Systolic blood pressure (mm Hg): After IV Propofol

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Immediately After IV Propofol

  11. Systolic blood pressure (mm Hg): At intubation (0 minute)

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: At intubation (0 minute)

  12. Systolic blood pressure (mm Hg): Post intubation (1 minute)

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (1 minute)

  13. Systolic blood pressure (mm Hg): Post intubation (3 minute)

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (3 minute)

  14. Systolic blood pressure (mm Hg): Post intubation (5 minute)

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (5 minute)

  15. Systolic blood pressure (mm Hg): Post intubation (10 minute)

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (10 minute)

  16. Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Baseline before IV fluid infusion

  17. Diastolic blood pressure (mm Hg): After IV Propofol

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Immediately After IV Propofol

  18. Diastolic blood pressure (mm Hg): At intubation (0 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: At intubation (0 minute)

  19. Diastolic blood pressure (mm Hg): Post intubation (1 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (1 minute)

  20. Diastolic blood pressure (mm Hg): Post intubation (3 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (3 minute)

  21. Diastolic blood pressure (mm Hg): Post intubation (5 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (5 minute)

  22. Diastolic blood pressure (mm Hg): Post intubation (10 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (10 minute)

  23. Mean arterial pressure (mm Hg): After IV Propofol

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Immediately After IV Propofol

  24. Mean arterial pressure (mm Hg): Baseline before IV fluid infusion

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Baseline before IV fluid infusion

  25. Mean arterial pressure (mm Hg): At intubation (0 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: At intubation (0 minute)

  26. Mean arterial pressure (mm Hg): Post intubation (1 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (1 minute)

  27. Mean arterial pressure (mm Hg): Post intubation (3 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (3 minute)

  28. Mean arterial pressure (mm Hg): Post intubation (5 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (5 minute)

  29. Mean arterial pressure (mm Hg): Post intubation (10 minute)

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

    Time frame: Post intubation (10 minute)

07

Study locations

1 of 1 sites recruiting
  • National Medical College Teaching Hospital
    Birgunj, Province - 2 44300, Nepal
    Recruiting
08

References and documents

Publications

  • Smith I, White PF, Nathanson M, Gouldson R. Propofol. An update on its clinical use. Anesthesiology. 1994 Oct;81(4):1005-43. No abstract available. PubMed 7943815 ↗
  • Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF, Apfelbaum JL, Grasela TH, et al. Hemodynamic effects of propofol: data from over 25,000 patients. Anesth Analg. 1993 Oct;77(4 Suppl):S21-9. PubMed 8214693 ↗
  • Van Aken H, Meinshausen E, Prien T, Brussel T, Heinecke A, Lawin P. The influence of fentanyl and tracheal intubation on the hemodynamic effects of anesthesia induction with propofol/N2O in humans. Anesthesiology. 1988 Jan;68(1):157-63. doi: 10.1097/00000542-198801000-00031. No abstract available. PubMed 3257362 ↗
  • Briggs LP, Dundee JW, Bahar M, Clarke RS. Comparison of the effect of diisopropyl phenol (ICI 35, 868) and thiopentone on response to somatic pain. Br J Anaesth. 1982 Mar;54(3):307-11. doi: 10.1093/bja/54.3.307. PubMed 6978144 ↗
  • McCollum JS, Milligan KR, Dundee JW. The antiemetic action of propofol. Anaesthesia. 1988 Mar;43(3):239-40. doi: 10.1111/j.1365-2044.1988.tb05551.x. PubMed 3259081 ↗
  • Williams EL, Hildebrand KL, McCormick SA, Bedel MJ. The effect of intravenous lactated Ringer's solution versus 0.9% sodium chloride solution on serum osmolality in human volunteers. Anesth Analg. 1999 May;88(5):999-1003. doi: 10.1097/00000539-199905000-00006. PubMed 10320158 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05777135
Lead sponsor
National Medical College Birgunj
Responsible party
Arushi Jaiswal (Postgraduate Doctor, National Medical College Birgunj) — Principal investigator
First posted
Mar 21, 2023
Start date
Apr 1, 2023
Primary completion
Mar 31, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Apr 5, 2023

Study contacts

Dr Arushi Jaiswal
Contact
arushij.dr16@gmail.com
+9779841675096

Oversight

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

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