Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP

NCT05996588 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SIUT-ERC-2021/A-325
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

After approval of ethical committee of Sindh Institute of Urology \& Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups

Conditions

Sedation Complication

Outcome Measures

Primary Outcomes (5)

• Ramsay sedation score

  Clinical Score Patient's Characteristics 1. Awake; agitated or restless or both 2. Awake; cooperative, oriented, and tranquil 3. Awake but responds to commands only 4. Asleep; brisk response to light glabellar tap or loud auditory stimulus 5. Asleep; sluggish response to light glabellar tap or loud auditory stimulus 6. Asleep; no response to glabellar tap or loud auditory stimulus

  0-2 hours

• Heart rate

  Heart rate via vitals monitoring device

  0-2 hours

• Mean arterial blood pressure

  Mean arterial blood pressure via a non-invasive blood pressure monitor

  0-2 hours

• Oxygen saturation

  Oxygen saturation via a pulse oximeter

  0-2 hours

• Respiratory rate

  Respiratory rate via a vitals monitoring device

  0-2 hours

Other Outcomes (2)

• Number of patients with post operative nausea

  0-2 hours

• Number of patients with post operative vomiting

  0-2 hours

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Propofol at a rate of 50 microgram/kg/min

Drug: Propofol 1 % Injectable Suspension

Sevoflurane

EXPERIMENTAL

Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25

Drug: Sevoflurane

Interventions

Propofol 1 % Injectable Suspension DRUG

Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously

Also known as: Propofol

Propofol

Sevoflurane DRUG

Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25

Also known as: Sevoflurane inhalation anaesthetic

Sevoflurane

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between age group of 20-60 years
• Both male and female patients.
• American Society of Anesthesiologist (ASA) physical status I-II
• Elective ERCP procedure.

You may not qualify if:

• Patients allergic to any study drug.
• American Society of Anesthesiology (ASA) Physical status III-IV
• Patients with uncontrolled Diabetes Mellitus,
• Hypertension and renal insufficiency.
• Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity)
• Obstructive Sleep Apnea
• Gastroesophageal reflux disease (GERD)
• Pregnancy

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Muhammad Q Abbas, FCPS

  Professor Dept of Anaesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 18, 2023
• Study Start: January 5, 2022
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)