Study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery if it Can Enhance Recovery From Anesthesia (modafinil)

August 11, 2025 updated by: foad farouk mohamed, Ain Shams University

Study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery

study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery if it Can Enhance Recovery From Anesthesia and provide improvement in recovery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted to 20 patients scheduled for bariatric surgeries. The study group (Modafinil group) received oral 200 mg modafinil 8 hours before surgery and then another 200 mg 2 hours before surgery. The other group (Placebo group) were given placebo through the same regimen as Modafinil. Immediate recovery time, cognitive recovery, emotional (general) status, discharge from PACU according to modified Aldrete score were assessed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Ain Shams University

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 aged from 18 to 60 years.
  2. Patients ASA II or III undergoing elective bariatric surgery.
  3. BMI 30-50 kg/m2.

Exclusion Criteria:

  1. Patient's refusal.
  2. Age below 18 or above 60y.
  3. History of cardiac disease.
  4. History or known allergy to Modafinil.
  5. Underlying liver or renal failure.
  6. Chronic neurological or psychiatric condition.
  7. Hemodynamically unstable patients.
  8. History of drug dependance.
  9. Habitual coffee consumption exceeding 2 cups per day.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 patients received modafinil preoperatively
assessing enhancement of recovery from anesthesia
Drug: Modafinil
dose of modafinil preoperatively for for active comparator
Placebo Comparator: 10 patients didnot receive modafinil preoperatively
Drug: Modafinil
dose of modafinil preoperatively for for active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
both groups were assessed as regard incidence of enhancement of immediate and cognitive recovery Comparison between groups as regard words recall as part of cognitive recovery data.
Time Frame: 1 day
Groups were compared in the primary outcome of our work (immediate recovery data) in OR by time intervals (T1, T2, T3 and T4) Comparison between groups as regard orientation as part of cognitive recovery score
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of difference of general and emotional status between both patients groups postoperatively
Time Frame: 24 hours
Groups were compared in assessment of general status and emotion and assessment of modified Aldrete score in PACU and compare between both groups
24 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Actual)

January 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

July 29, 2025

First Submitted That Met QC Criteria

August 11, 2025

First Posted (Actual)

August 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAMSU MS 412/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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