Skip to main content
OpenTrials
Completed

NCT Number: NCT00376831

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.

There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.

This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.

The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.

The results will be compiled from objective data and patient and physician interviews.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Conscious Sedation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soroka Medical Center

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.

Exclusion criteria

  • Hypersensitivity to benzodiazepines
  • Hypersensitivity to benzyl alcohol
  • Hypersensitivity to ketamine
  • Hypersensitivity to opiates
  • Pregnancy
  • Uncontrolled hypertension
  • Myocardial infarct in the last 6 months
  • CVA
  • Chronic pulmonary disease
  • Renal failure
  • Chronic liver disease (CHILD B or C)
  • Elevated ICP, cerebral hemorrhage or cranial SOL.
  • Hypovolemic shock
  • Glaucoma
  • Mental illness
  • Drug or alcohol addiction

Treatment and study plan

Midazolam, Fentanyl

Drug

fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

KETAMINE, MIDAZOLAM

Drug

Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg

Primary outcomes

  1. Recovery time

    Time frame: 24 hours following colonoscopy

Secondary outcomes

  1. Sedative effect

    Time frame: 24 hours following colonoscopy

  2. Patient compliance

    Time frame: 24 hours following colonoscopy

  3. Side effects

    Time frame: 24 hours following colonoscopy

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Sep 15, 2006
Registry last updated
Aug 10, 2007

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.