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RecruitingNCT06414395Updated May 16, 2024

The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

A Phase 4 interventional study of Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection and C group: Patients received saline infusion over 10 minutes in GIT Endoscopy and Procedural Sedation, sponsored by Theodor Bilharz Research Institute. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Theodor Bilharz Research Institute · Phase 4, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications.

Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression.

Studies are ongoing to find the optimal use of dexmedetomidine for these procedures. A combination of propofol and dexmedetomidine might be ideal, but the best balance between the two drugs needs further investigation.

Read the detailed description

Advanced upper gastrointestinal tract procedures such as Endoscopic retrograde cholangiopancreatography (ERCP) \& Endoscopic ultrasound (EUS) are very important diagnostic and therapeutic procedures for the diagnosis \& management of many pancreatobiliary pathologies whether benign or malignant (1-4). These procedures require moderate-deep sedation with the patient lying in the lateral or semi-prone position to provide the operator easier access \& insertion while permitting fluoroscopic visualisation (1-4).

Propofol sedation is currently the most popular drug used for advanced endoscopic procedures because of its shorter half-life which results in a shorter recovery time than conventional sedation (benzodiazepine \&/or opioid) (5). Propofol was administered initially by intermittent boluses but later on was superseded by continuous infusion guided by clinical scoring, e.g., Ramsey sedation score (6), by target-controlled infusion (TCI) (7) or more recently by bispectral index (BIS) monitoring (8).

Propofol, however, has a narrow therapeutic window that may cause fluctuation of the level of sedation from moderately deep sedation to near general anesthesia. Not only that but also propofol sedation is associated with many other complications including apnoea, airway obstruction desaturation, hypotension, bradycardia, gagging, restlessness, regurgitation \& vomiting \& delayed recovery (9).

Dexmedetomidine, a highly specific, potent and selective α2-adrenoceptor agonist, was originally introduced as a sedative for critically ill mechanically ventilated patients [9]. In addition to sedation, it has a group of unique properties in the form of analgesia, reduction of sympathetic tone and attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery with minimal respiratory depression, making it an attractive agent for perioperative sedation especially in remote areas outside the operating theatres (6,10).

The quest to replace propofol coupled with the unique sedo-analgesic properties of dexmedetomidine resulted in the interest in the use of dexmedetomidine for providing sedation for advanced endoscopic procedure (6,10).

In 2021, Srivastava et al (6), studied the effects dexmedetomidine as a sole sedative agent in the form of a loading dose of 1 µg.kg-1 followed by 0.5 µg.kg-1.hr-1 continuous infusion. They reported that although this dexmedetomidine regimen produced adequate sedation in many patients yet it was associated with a relatively high sedation failure rate requiring rescue propofol boluses (6). Moreover, dexmedetomidine was associated with bradycardia \& hypotension (6,7,11).

It was 2013, When Wang et al (12), examined the propofol sparing effect of various dexmedetomidine loading doses ranging between 0.25 \& 1 µg.kg-1 followed by a fixed infusion of 0.5 µg.kg-1.hr-1 and reported a dose dependent reduction of propofol requirements for induction of sedation (12). However, they did not investigate the impact of these dexmedetomidine doses on the total propofol consumption for the whole procedure, the incidence of adverse events or the recovery profile of such a combination in the context of sedation for advanced endoscopic procedures. Thus, the" sweet spot" (13), where there is a maximal synergism between propofol and dexmedetomidine, is still to be identified.

02

Conditions studied

  • GIT Endoscopy
  • Procedural Sedation
03

In context

Lead sponsor

Theodor Bilharz Research Institute is the lead sponsor of 36 studies on the registry; 2 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

Inclusion criteria

  • Patients aged 18-65
  • Both sexes
  • ASA I-II
  • BMI \<35

Exclusion criteria

Exclusion Criteria:

  • Patients' refusal to participate
  • ASA III-IV
  • BMI > 35
  • Patients who are considered high aspiration risk, e.g., gastric outlet obstruction
  • Allergy to any medications used
  • Diabetics
  • Any patient receiving cardioactive drugs, e.g., Beta blockers, Calcium channel blockers, Inhaled B2 bronchodilators)
  • Patients with Pacemakers or heart rate below 50 beat/min
  • Pregnant women
  • Habitual Drug abusers
  • Patients who had to be intubated during the procedure.
05

Study design

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

Study arms

  • Experimental
    The Dexmedetomidine Group D1

    D1 group will receive 1µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg.

    Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

  • Experimental
    The Dexmedetomidine Group D 0.5

    D 0.5 group will receive 0.5 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

    Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

  • Experimental
    The Dexmedetomidine Group D0.25

    D 0.25 group will receive 0.25 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

    Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

  • Placebo comparator
    The Dexmedetomidine Group D 0

    D 0 group will receive a placebo saline infusion over 10 minutes and then will receive 50 ml of normal saline as a placebo

    Other: C group: Patients received saline infusion over 10 minutes

Interventions

  • DrugPrecedex (Dexmedetomidine) 200 MCG in 2 ML Injection

    The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

  • OtherC group: Patients received saline infusion over 10 minutes

    the group will receive normal saline infusion over 10 minutes.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. • Recovery time of each group: the time from ending the infusions till a modified Aldrete score (MAS) score of ≥ 9 is reached.

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Theodor Bilharz Research Institute
    Cairo, Giza 12411, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06414395
Lead sponsor
Theodor Bilharz Research Institute
Responsible party
Sameh Mohamed Elaidy (Assistant lecturer, Theodor Bilharz Research Institute) — Principal investigator
First posted
May 16, 2024
Start date
May 1, 2024
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
May 16, 2024

Study contacts

Sameh M. Elaidy, Msc.
Contact
sameh.elaidy@hotmail.com
1111776906 ext. +20
Nabawya Kamel, Proffessor
Contact
n.kamal21@hotmail.com
1066175989 ext. +20

Oversight

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

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