Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

V

VA Connecticut Healthcare System

Status

Completed

Conditions

Sedation
Endoscopy

Treatments

Drug: Midazolam
Drug: Diphenhydramine

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01769586
0003

Details and patient eligibility

About

Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Full description

Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine (up to 3 incremental doses of 25 mcg each) vs. continued midazolam (up to 3 incremental doses of 1.5 mg each). the level of sedation will be assessed using the MOAA/S scale 2-3 minutes after each administration to determine if they are sufficiently sedated to begin colonoscopy. The patient, the healthcare team involved in performing the endoscopy, and the investigator assessing sedation will be blinded to the therapy. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients >18 years-old who are undergoing elective colonoscopy with conscious sedation

Exclusion criteria

  • allergy or prior adverse reactions to diphenhydramine
  • medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
  • pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups

Diphenhydramine
Active Comparator group
Description:
Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Treatment:
Drug: Diphenhydramine
Midazolam
Active Comparator group
Description:
1.5 mg increments up to 3 times (maximum 4.5 mg)
Treatment:
Drug: Midazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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