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

NCT05529004 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: pregabalin and PONV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea, vomiting, cholecystectomy, oral pregapalin

Outcome Measures

Primary Outcomes (1)

• Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.

  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.

  Baseline

Study Arms (2)

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

EXPERIMENTAL

participants receive pregapalin 75mg cap orally 30 min before surgery

Drug: Oral Capsule pregapalin; Device: laparoscope device

placebo

NO INTERVENTION

participants hasn't receive pregapalin capsule

Interventions

Oral Capsule pregapalin DRUG

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

Also known as: general anesthesia

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

laparoscope device DEVICE

general anesthesia with complete relaxation under laparoscopic cholecystectomy

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Safwa University College: lead

Related Publications (6)

• Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236.

  PMID: 15064261 BACKGROUND

• Koivuranta MK, Laara E, Ryhanen PT. Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial. Anaesthesia. 1996 Jan;51(1):52-55. doi: 10.1111/j.1365-2044.1996.tb07654.x.

  PMID: 8669567 BACKGROUND

• Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.

  PMID: 32467512 BACKGROUND

• Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.

  PMID: 16846542 RESULT

• Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.

  PMID: 7986507 RESULT

• Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.

  PMID: 17885699 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Anesthesia, General; Laparoscopes

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Mohammed abdulzahra sasaa, phd

CONTACT

009647718991533; m.abedalzahraa@alsafwa.edu.iq

Ahmed AN sahib, phd

CONTACT

009647815759208; smralmmwry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthetist

Model Details: Randomized Double Blind study.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share