Conscious Sedation for Outpatient Colonoscopy
- Conditions
- Conscious Sedation
- Interventions
- Registration Number
- NCT03925779
- Lead Sponsor
- Menoufia University
- Brief Summary
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
- Detailed Description
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- ASA I or II physical status
- 18-65 years
- Scheduled for elective colonoscopy
- History of allergy to any of the study drugs
- Alcohol or drug abuse.
- Second and third-degree heart block.
- Morbid obesity.
- Pregnant and lactating women.
- Psychiatric disorders.
- Severe cardiac, respiratory, renal, and liver diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Dexmedetomidine)Dex group Dexmedetomidine The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure Propofol-Remifentanil (P-R) group Propofol Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. Propofol-Remifentanil (P-R) group Remifentanil Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.
- Primary Outcome Measures
Name Time Method Sedation Perioperative Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
- Secondary Outcome Measures
Name Time Method Oxygen saturation Perioperative Arterial oxygen saturation as a percentage of the total haemoglobin.
Hypotension Perioperative Number of patients with hypotension
Bradycardia Perioperative Number of patients with bradycardia
Mean arterial blood pressure Perioperative Mean arterial blood pressure in mmHg
Heart rate Perioperative Heart rate in beats/minutes
Analgesia Perioperative Measured by visual analogue scale \[from 0 "no pain" to 10 "worst imaginable pain"\]
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Cairo, Shebin El-kom, Egypt