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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT07190495

Postoperative Nausea and Vomiting Laparoscopic Cholecystectomy

RECRUITING PHASE4

Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

NCT03202459

Postoperative Complications Postoperative Nausea and Vomiting

UNKNOWN NA

Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.

NCT05317611

Prevention

COMPLETED NA

Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery

NCT03459248

Postoperative Nausea and Vomiting

COMPLETED NA

Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

NCT05998317

Postoperative Nausea and Vomiting Postoperative Pain Laparoscopic Cholecystectomy

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Double Blind study.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.

participants receive pregapalin 75mg cap orally 30 min before surgery

Group Type EXPERIMENTAL

Oral Capsule pregapalin

Intervention Type DRUG

oral cap of pregapalin has been administration to patient before surgery to prvent PONV

laparoscope device

Intervention Type DEVICE

general anesthesia with complete relaxation under laparoscopic cholecystectomy

placebo

participants hasn't receive pregapalin capsule

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Capsule pregapalin

oral cap of pregapalin has been administration to patient before surgery to prvent PONV

Intervention Type DRUG

laparoscope device

general anesthesia with complete relaxation under laparoscopic cholecystectomy

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

general anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes