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

NCT ID: NCT07128719

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obese Adolescents Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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10 patients received modafinil preoperatively

assessing enhancement of recovery from anesthesia

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type DRUG

dose of modafinil preoperatively for for active comparator

10 patients didnot receive modafinil preoperatively

Group Type PLACEBO_COMPARATOR

Modafinil

Intervention Type DRUG

dose of modafinil preoperatively for for active comparator

Interventions

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Modafinil

dose of modafinil preoperatively for for active comparator

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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foad farouk mohamed

lecturer of anesthesia, ICU and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FAMSU MS 412/2023

Identifier Type: -

Identifier Source: org_study_id

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