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

Not Applicable

Completed

• Conditions: Obese Adolescents; Bariatric Surgery
• Interventions: Drug: Modafinil

• Registration Number: NCT07128719
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2024-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 patients received modafinil preoperatively	Modafinil	assessing enhancement of recovery from anesthesia
10 patients didnot receive modafinil preoperatively	Modafinil	-

Primary Outcome Measures

Name	Time	Method
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.	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

Secondary Outcome Measures

Name	Time	Method
assessment of difference of general and emotional status between both patients groups postoperatively	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt