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NCT Number: NCT07128719

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 if it Can Enhance Recovery From Anesthesia and provide improvement in recovery

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Key information

Conditions

Obese Adolescents Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Modafinil

Drug

dose of modafinil preoperatively for for active comparator

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: modafinil

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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