Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05996588
• Other study ID #: SIUT-ERC-2021/A-325
• Status: Completed
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: November 25, 2022

Study information

• Verified date: August 2023
• Source: Sindh Institute of Urology and Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation Complication

Intervention

Drug:
• Propofol 1 % Injectable Suspension
Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously
• Sevoflurane
Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25

Locations

Country	Name	City	State
Pakistan	Syed Muhammad Abbas	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Sindh Institute of Urology and Transplantation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with post operative nausea	Feeling of patient to vomit out	0-2 hours
Other	Number of patients with post operative vomiting	Expulsion of stomach contents	0-2 hours
Primary	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
Primary	Heart rate	Heart rate via vitals monitoring device	0-2 hours
Primary	Mean arterial blood pressure	Mean arterial blood pressure via a non-invasive blood pressure monitor	0-2 hours
Primary	Oxygen saturation	Oxygen saturation via a pulse oximeter	0-2 hours
Primary	Respiratory rate	Respiratory rate via a vitals monitoring device	0-2 hours