search
Back to results

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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oral Capsule pregapalin
laparoscope device
Sponsored by
Al Safwa University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring nausea, vomiting, cholecystectomy, oral pregapalin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

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

    placebo

    Arm Description

    participants receive pregapalin 75mg cap orally 30 min before surgery

    participants hasn't receive pregapalin capsule

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2022
    Last Updated
    September 1, 2022
    Sponsor
    Al Safwa University College
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05529004
    Brief Title
    A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
    Official Title
    Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al Safwa University College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting
    Keywords
    nausea, vomiting, cholecystectomy, oral pregapalin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Double Blind study.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.
    Arm Type
    Experimental
    Arm Description
    participants receive pregapalin 75mg cap orally 30 min before surgery
    Arm Title
    placebo
    Arm Type
    No Intervention
    Arm Description
    participants hasn't receive pregapalin capsule
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Capsule pregapalin
    Other Intervention Name(s)
    general anesthesia
    Intervention Description
    oral cap of pregapalin has been administration to patient before surgery to prvent PONV
    Intervention Type
    Device
    Intervention Name(s)
    laparoscope device
    Intervention Description
    general anesthesia with complete relaxation under laparoscopic cholecystectomy
    Primary Outcome Measure Information:
    Title
    Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
    Description
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed abdulzahra sasaa, phd
    Phone
    009647718991533
    Ext
    AZ
    Email
    m.abedalzahraa@alsafwa.edu.iq
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed AN sahib, phd
    Phone
    009647815759208
    Email
    smralmmwry@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15064261
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8669567
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32467512
    Citation
    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. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
    Results Reference
    background
    PubMed Identifier
    16846542
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    7986507
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    17885699
    Citation
    Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs