Conscious Sedation for Outpatient Colonoscopy

Menoufia University

Status and phase: Completed; Phase 2

Conditions: Conscious Sedation

Treatments: Drug: Dexmedetomidine; Drug: Propofol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03925779

2019/3/15/9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I or II physical status
• 18-65 years
• Scheduled for elective colonoscopy

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

(Dexmedetomidine)Dex group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Propofol-Remifentanil (P-R) group

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol