Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP

Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography

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

Study Overview

• Status: Completed
• Conditions: Sedation Complication
• Intervention / Treatment: Drug: Propofol 1 % Injectable Suspension; Drug: Sevoflurane

Detailed Description

After approval of ethical committee of SIUT, 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by history of patients, general physical examination, systematic examination, and laboratory investigations. 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/Kilogram/min started for maintenance of anaesthesia.

When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2), noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and baseline readings will be recorded. After that venous access was secured on a non-dominant hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8 ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken, after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure ends.

Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more than 10 seconds or patient developed apnea, it was considered oxygen desaturation.

Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40 beats per minute was considered bradycardia and it will be managed by inj Atropine 10 ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or 20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or vasopressors.

After the procedure, patients were awakened and shifted to recovery room. Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated accordingly.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Syed Muhammad Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Propofol at a rate of 50 microgram/kg/min	Drug: Propofol 1 % Injectable Suspension; Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously; Other Names: Propofol
Experimental: Sevoflurane; Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25	Drug: Sevoflurane; Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25; Other Names: Sevoflurane inhalation anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ramsay sedation score	Clinical Score Patient's Characteristics; Awake; agitated or restless or both; Awake; cooperative, oriented, and tranquil; Awake but responds to commands only; Asleep; brisk response to light glabellar tap or loud auditory stimulus; Asleep; sluggish response to light glabellar tap or loud auditory stimulus; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with post operative nausea	Feeling of patient to vomit out	0-2 hours
Number of patients with post operative vomiting	Expulsion of stomach contents	0-2 hours

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Study Chair: Muhammad Q Abbas, FCPS, Professor Dept of Anaesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): November 25, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics; Propofol; Sevoflurane; Anesthetics, Inhalation
• Other Study ID Numbers: SIUT-ERC-2021/A-325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes