Sedation in Patients Undergoing GIT Endoscopy

August 15, 2023 updated by: Noura Hasan Attia, Assiut University

Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy

Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopy plays a significant role in the diagnosis and treatment of gastrointestinal diseases. Sedation has been used in clinical practice to make the procedure more comfortable, and improve patient satisfaction by helping patients rest during the procedure. (1) (2) The most common complications in gastrointestinal endoscopy are not related to the procedure, but are related to sedation; they include cardio-respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vaso-vagal episodes (3).

Many studies have reported on use of propofol as a single agent for sedation during endoscopy. However propofol is often used in combination with another agent for other indications. The benefit of propofol in terms of shorter recovery and discharge times and higher patient satisfaction persists, when it is used in combination with other agents.

Propofol has limited analgesic effect and higher doses are often required, when it is used as a single agent for endonoscopy, resulting in higher sedation levels. Thus use of propofol in combination with other agents may be preferable to propofol alone. The combination may be easier to manage due to lower sedation levels and ability to reverse some of the sedation with the use of reversal agents for narcotics (4).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Patients scheduled for GIT endoscopy 2. Age 18-60 years old 3. ASA I-II. 4. BMI less than 30

Exclusion Criteria:

  • 1. Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) 2. pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer) 3. central nervous system abnormality 4. allergy to the study drugs 5. habitual sedative or analgesic use 6. pregnancy 7. Anticipated difficult airway.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol and nalbuphine group
Drug: propofol and magnesium sulphate ,propofol and nalbuphine

The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration.

All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation.
Active Comparator: Propofol and magnesium sulfate group
Drug: propofol and magnesium sulphate ,propofol and nalbuphine

The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration.

All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of patient sedation
Time Frame: the time of endoscopy
The level of patient sedation using Ramsay sedation agitation score (before induction of sedation (T0), 5 minutes after sedation (T1), 10 minutes after sedation (T2), and then every 30 minutes till complete recovery (T3, T4 and T5) to assess the depth of anesthesia.
the time of endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hamdy Abbas Youssef, Professor, Assiut University
  • Study Director: Ola Mahmoud Wahba, Assistant Professor, Assiut University
  • Study Director: Khaled Tolba Younes, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In the future

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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