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Comparison of sedative and analgesic effect of dexmedetomidin and fentanyl versus midazolam and fentanyl during colonoscopy

Comparison of sedative and analgesic effect of dexmedetomidin and fentanyl versus midazolam and fentanyl during colonoscopy: A double blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201603057752N9
Enrollment
60
Registered
2016-06-26
Start date
2016-07-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pain. acute pain

Interventions

Intervention 1: administration of dexmedetomidine 1 mg per kg over 10 minutes and then 0.5 mg per kilogram per minute and fentanyl 0.5 microgram per kg. Intervention 2: the control group receives mida
Treatment - Drugs
administration of dexmedetomidine 1 mg per kg over 10 minutes and then 0.5 mg per kilogram per minute and fentanyl 0.5 microgram per kg
the control group receives midazolam 0.5 mg per kg maximum to 2.5 mg and fentanyl 0.5 microgram per kg

Sponsors

Babol University of Medical Sciences, Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 20-70 years; ASA class = 3 Exclusion criteria: age 70 years; heart disease (arrhythmia, aortic stenosis, ischemic heart disease,heart failure) ; liver disease (Child-Pugh classification C);kidney disease ; lack of patient cooperation;mental illness (major Depression, mania, psychosis); hypotension; hypertension; drug addiction.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: During and until 2 hours after colonoscopy. Method of measurement: Ramsay sedation scale.;Pain. Timepoint: 12 hours after colonoscopy. Method of measurement: Visoal analoge Scale.

Secondary

MeasureTime frame
Mean arterial pressure. Timepoint: During and until 2 hours after colonoscopy. Method of measurement: mm hg.;Resoiratory rate. Timepoint: During and 2 hours after colonoscopy. Method of measurement: Number per minutes.;Heart rate. Timepoint: During and until 2 hours afer colonoscopy. Method of measurement: Number per minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmri Maleh Parviz

Babol University of Medical Sciences

pamrimaleh@yahoo.com+98 11 4207 4589

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026