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

NCT07128719 | Completed DMC

• 1 other identifier: FAMSU MS 412/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Obese Adolescents; Bariatric Surgery

Keywords

bariatric surgery; obesity; modafinil; recovery from anethesia

Outcome Measures

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.

  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 Outcomes (1)

• assessment of difference of general and emotional status between both patients groups postoperatively

  24 hours

Study Arms (2)

10 patients received modafinil preoperatively

ACTIVE COMPARATOR

assessing enhancement of recovery from anesthesia

Drug: Modafinil

10 patients didnot receive modafinil preoperatively

PLACEBO COMPARATOR

Drug: Modafinil

Interventions

Modafinil DRUG

dose of modafinil preoperatively for for active comparator

10 patients didnot receive modafinil preoperatively; 10 patients received modafinil preoperatively

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, ICU and pain management

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 19, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)