Comparison of Post Anesthetic Recovery Time in Sedated Patients for Colonoscopy

NCT03813303 | Completed Phase 4

• 1 other identifier: CAAE56538616230015121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is an important diagnostic and therapeutic tool in colon disorders. Different drugs and levels of sedation can be used in its accomplishment. There is no consensus on which is the ideal. The aim of this study was to compare the post anesthetic recovery time between patients deeply sedated with midazolam and propofol or fentanyl and propofol. 50 American Society of Anesthesiologist physical state (ASA) I and II candidates elective colonoscopy at Luxembourg Hospital were divided into two groups A) midazolam and propofol or B) fentanyl and propofol. Time of examination, post anesthetic recovery and discharge at home, intercurrence and propofol consumption were compared.

Conditions

Colonoscopy; Anesthesia

Keywords

Colonoscopy; Anesthesia; Fentanyl; Midazolam; Propofol

Outcome Measures

Primary Outcomes (1)

• Recovery time

  The main objective was to compare post-anesthetic recovery times, defined as a score greater than or equal to 9 on the Aldrete scale, in patients submitted to two sedation regimens: midazolam with propofol or fentanyl with propofol. Aldrete scale is a post anesthesic recovery scale that ranges from 0 to 10, meaning complete recovery in values above nine.

  An average of two hours after the termination of the procedure.

Study Arms (2)

Midazolam group

ACTIVE COMPARATOR

Midazolam and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist . Complications and procedure and recovery times were recorded for comparison with the Fentanyl group.

Drug: Midazolam; Drug: Propofol

Fentanyl group

ACTIVE COMPARATOR

Fentanyl and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist .Complications and procedure and recovery times have were recorded for comparison with the Midazolam group.

Drug: Fentanyl; Drug: Propofol

Interventions

Midazolam DRUG

Administration of midazolam by anesthesiologist for sedation.

Midazolam group

Fentanyl DRUG

Administration of fentanyl by anesthesiologist for sedation.

Fentanyl group

Propofol DRUG

Administration of propofol by anesthesiologist for sedation.

Fentanyl group; Midazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and II physical status patients scheduled for elective colonoscopy.

You may not qualify if:

• BMI less than 17 or over 30
• allergy to any medication used,
• cognitive difficulty,
• psychiatric disorder,
• hospitalization,
• chronic use of opioids.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Luxemburgo Hospital

Belo Horizonte, Minas Gerais, 30380-472, Brazil

Location

MeSH Terms

Interventions

Midazolam; Fentanyl; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Renato Gomez

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 23, 2019
• Study Start: March 20, 2018
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)