Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05103410
Other study ID # FMASU R 175/2021
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 10, 2021
Est. completion date January 10, 2023

Study information

Verified date February 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The analgesic effect of perioperative use of aripiprazole has not been fully investigated. So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 10, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Physical status American Society of Anesthesiologist (ASA) I or II - Electively scheduled for laparoscopic hysterectomy, Exclusion Criteria: - Patients who refuse to participate - Body mass index (BMI) > 30 - ASA physical status > II - Diabetes - Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) - Coagulation abnormalities - Pregnancy - Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis) - History of drug addiction or alcohol abuse - Mental retardation interfering with the evaluation of pain scores or PCA programs .

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ARIPiprazole 30 MG
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Placebo
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery

Locations

Country Name City State
Egypt Ain Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary First time to analgesic requirement After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser PlusĀ® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time. First 24 hours postoperatively
Secondary Total opioid consumption Total morphine consumption per twenty four hours will be estimated First 24 hours postoperatively
Secondary Visual analogue scale (VAS) Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively First 24 hours postoperatively
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas