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NCT Number: NCT05996588

Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 1 % Injectable Suspension

Drug

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

Other names: Propofol

Sevoflurane

Drug

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

Other names: Sevoflurane inhalation anaesthetic

Primary outcomes

  1. Ramsay sedation score

    Time frame: 0-2 hours

    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
  2. Heart rate

    Time frame: 0-2 hours

    Heart rate via vitals monitoring device

  3. Mean arterial blood pressure

    Time frame: 0-2 hours

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

  4. Oxygen saturation

    Time frame: 0-2 hours

    Oxygen saturation via a pulse oximeter

  5. Respiratory rate

    Time frame: 0-2 hours

    Respiratory rate via a vitals monitoring device

Other outcomes

  1. Number of patients with post operative nausea

    Time frame: 0-2 hours

    Feeling of patient to vomit out

  2. Number of patients with post operative vomiting

    Time frame: 0-2 hours

    Expulsion of stomach contents

Sponsors and collaborators

Lead sponsor

Sindh Institute of Urology and Transplantation

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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