Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06148103
Other study ID # 00385
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2021
Est. completion date May 6, 2023

Study information

Verified date November 2023
Source Zulekha Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.


Description:

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation. Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 6, 2023
Est. primary completion date May 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility - Inclusion Criteria: 1. both sexes 2. 21-60 years old, with 3. ASA physical status - - Exclusion Criteria: - severe cardiovascular or respiratory disease - (ASA grade =III) - pregnancy - allergies to the drugs being used - known alcohol or substance abuse - expected communication difficulties with the patient.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Patients who received Dexmedetomodine
1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 µg/kg/h).
patients who received propofol-fentanyl
Continued infusions of both fentanyl and propofol were 0.01-0.05 µg kg/ min 25-150 mg/h respectively.

Locations

Country Name City State
Egypt Al-Azhar faculty of medicine Cairo

Sponsors (2)

Lead Sponsor Collaborator
Zulekha Hospitals Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The quality of painless sedation during colonoscopy. The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS). From start of procedure to 120 minutes after end of colonoscopy
Secondary incidence of adverse events, Prevalence of adverse effects incidence of adverse events, hemodynamic instability, failure to provide adequate sedation. from start of procedure to 120 minutes after end of colonoscopy
See also
  Status Clinical Trial Phase
Completed NCT04027933 - Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Not yet recruiting NCT05614687 - Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria N/A
Completed NCT05828264 - The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children N/A
Completed NCT04755998 - Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations N/A
Completed NCT04299555 - Assessment of Fears of Patients Standing at the Operating Block
Active, not recruiting NCT03993509 - Effect of rTMS on Anxiety N/A
Completed NCT06011668 - EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN N/A
Completed NCT05930015 - Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China N/A
Recruiting NCT06004115 - Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression Phase 4
Recruiting NCT06257186 - Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study N/A
Recruiting NCT03821779 - Prefrontal Oscillations in Social Anxiety Disorder (POSAD) N/A
Recruiting NCT06436079 - Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber N/A
Completed NCT06336811 - Virtual Reality Distraction During Phlebotomy in Children N/A
Recruiting NCT05548699 - Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
Recruiting NCT04406181 - Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic N/A
Completed NCT04821960 - Memory and Fear Study (Fear of Memory Loss Study) N/A
Completed NCT06415188 - The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction N/A
Completed NCT04631172 - Covid-19 Anxiety and Phobia Levels of the Parents
Active, not recruiting NCT04385732 - Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients N/A