A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy

Phase 2

Not yet recruiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Oral Capsule pregapalin; Device: laparoscope device

• Registration Number: NCT05529004
• Lead Sponsor: Al Safwa University College

Brief Summary

As long as anesthesia is administered, postoperative nausea and vomiting (PONV) will continue to be a frequent and upsetting comorbidity. Vomiting and nausea can significantly slow down recovery, raise staffing and drug expenses, and decrease patient satisfaction during perioperative procedures.

Nausea it is a conscious recognition of subconscious excitation in area of medulla closely associated with or a part of the vomiting center, or it is sensation of discomfort at upper abdomen and unease sensation with involuntary order to vomit. While vomiting It is a mean by which the upper GIT rides of its contents when any part of upper GIT becomes irritated, over distended or over excitable.

The PONV is the most feared postoperative symptoms \& it may impaired dressing , surgical repairs \& increased ( bleeding , pain , risk of gastric contents aspiration ) \& if it is prolonged will leads to electrolytes , fluid imbalance \& dehydration ; the PONV can occurs after up to 90 % of operative procedures ; The common risk factors of PONV are : young age , female gender, history of ( PONV , motion sickness ) , those not smokers , early mobilization after surgery , early drinking \& eating after operations , procedures like (laparoscopic , gynecological , abdominal , ENT , squint ) , postoperative severe pain , narcotic premedication , possibly prolonged general anesthesia , gastric distention , stimulation of the pharynx , hypoxemia , hypotension , \& dehydration.

The PONV can reduced by: avoidance of triggers where possible, uses of anti-emetics drugs, techniques \& procedures associated with low incidence of PONV (e.g. propofol) \& give intravenous fluids; with prophylaxis the incidence is usually under 30% in high risk cases, the most effective approach for prevention of PONV is the use of multiple strategies \& different drugs.

The pregabalin (C8H17NO2), is a newer drug \& recently introduced at 1990. as anticonvulsive medication. We evaluated the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.

Detailed Description

Pregabalin has been found to minimize the need for opioid as well as non-steroid anti-inflammatory medications and relieve pain with different type of surgery, along with consideration of a diverse mechanisms, preoperative oral pregabalin has been reported to have antiemetic effect postoperatively. postoperative laparoscopic cholecystectomy, are associated with nausea and Vomiting and it's a concern that dictates the need for antiemetic which gives intravenously; as the intravenous drugs with intravenous fluid is becoming more common, the use of oral pregabalin is frequently mentioned, on the other hand, the intravenous antiemetic medication has some side effect.

Aim of the study:

To evaluate the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.

Design: Randomized Double Blind study.

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study Start: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2022-10-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 - < 55 years.
• Both gender (male & female).
• Patients ASA physical status1.
• Procedures with high risk of postoperative nausea & vomiting.
• Elective operations under general anesthesia with laparoscopic cholecystectomy.

Exclusion Criteria

• Age ≥ 55 years.
• Emergency operations,
• Patient refusal, allergy to pregabalin.
• Pregnant patients, patients taken preoperative anti-emetic medications.
• Patients with cardiac respiratory endocrine diseases.
• Total intravenous maintenance general anesthesia and thiopental as induction agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.	Oral Capsule pregapalin	participants receive pregapalin 75mg cap orally 30 min before surgery
Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.	laparoscope device	participants receive pregapalin 75mg cap orally 30 min before surgery

Primary Outcome Measures

Name	Time	Method
Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.	Baseline	Analysis of pregabalin group compare with the control group in laparoscopic cholecystectomy patients. to fined effective of oral pregapaline on PONV. we assess the incidence of postoperative nausea and vomiting by the use of Koivuranta Score.