Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

Aim of the study is to evaluate the discharge time and patient satisfaction after Remifentanil infusion in patients undergoing endoscopies.

Based on previous literature, the sample size required will be 74 participants with power (1-β) 80% and level of significance(α) at 5%.

Method:

Routinely patients undergo endoscopies under iv midazolam sedation alone or in combination with iv fentanyl given as bolus doses as required. They are provided O2 via facemask and vitals (Heart rate, SpO2 and BP) are monitored during the procedure.

Study procedure:

Patients will be instructed to attend the endoscopy unit with two hours fasting for clear liquids and 6 hours for solid foods. A 20 gauge iv canula will be secured on arrival to the endoscopy room. Patients will be given iv Remifentanil infusion at a dose of 0.25 - 1 μgm/kg/minute along with 1 mg of iv Midazolam bolus dose. The procedure will start after one minute of starting the Remifentanil infusion. A baseline and intraprocedural Ramsay sedation score will be recorded as assessed by the attending anaesthesiologist. Intraprocedural HR, BP, ETCO2 and SpO2, total and supplemental dose of Remifentanil will be recorded. The Remifentanil infusion will be stopped on withdrawal of the endoscope. The time of discharge after sedation based on MPADSS will be assessed by the recovery nurse and entered into the proforma. Any adverse events (like nausea, vomiting) will also be entered into the proforma. Any bradycardia will be treated with atropine. Nausea/ vomiting if any will be treated with iv ondansetron 0.1mg/kg. Patient satisfaction will be assessed after the procedure using the VAS. The Surgeon’s satisfaction will also be assessed using VAS. The patient sedation score and time to recovery from Remifentanil will be compared with the existing data of midazolam/fentanyl sedation.