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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07128719
Acronym
modafinil
Enrollment
20
Registered
2025-08-19
Start date
2024-01-01
Completion date
2025-06-01
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obese Adolescents

Keywords

bariatric surgery, obesity, modafinil, recovery from anethesia

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.

Interventions

DRUGModafinil

dose of modafinil preoperatively for for active comparator

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 dayGroups 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

MeasureTime frameDescription
assessment of difference of general and emotional status between both patients groups postoperatively24 hoursGroups were compared in assessment of general status and emotion and assessment of modified Aldrete score in PACU and compare between both groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026