search
Back to results

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

Primary Purpose

Prevention

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Intraperitoneal instillation of ondansetron and bupivacaine
Intravenous ondansetron and intraperitoneal instillation of bupivacaine
Intraperitoneal instillation of bupivacaine
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prevention

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent from the patient.
  • Age: 21-45 years old.
  • Both sex.
  • Physical status: ASA 1& II.
  • BMI = (25-35 kg/m2).
  • Type of operation: elective laparoscopic gynecological surgeries.

Exclusion Criteria:

  • Altered mental state.
  • Patients with known history of allergy to the study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain received NSAID or opioid during previous two weeks.
  • Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Intraperitoneal instillation of ondansetron and bupivacaine (group A)

    Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)

    Intraperitoneal instillation of bupivacaine (group C)

    Arm Description

    Patients will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.

    Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.

    patient will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.

    Outcomes

    Primary Outcome Measures

    measure incidence and severity of postoperative nausea and vomiting
    using Rohdes Index of Nausea, Vomiting, and Retching it is questionnaire of 8 items with minimum score =0 and maximum score =4 for each item.

    Secondary Outcome Measures

    measure total numbers of rescue antiemetic
    patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately
    Duration of hospital stay
    time from PACU discharge till time to discharge home

    Full Information

    First Posted
    March 30, 2022
    Last Updated
    April 7, 2022
    Sponsor
    Zagazig University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05317611
    Brief Title
    Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.
    Official Title
    Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    October 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
    Detailed Description
    Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting. There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain). Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic gynecological surgeries.
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters
    Allocation
    Randomized
    Enrollment
    63 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intraperitoneal instillation of ondansetron and bupivacaine (group A)
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
    Arm Title
    Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)
    Arm Type
    Active Comparator
    Arm Description
    Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
    Arm Title
    Intraperitoneal instillation of bupivacaine (group C)
    Arm Type
    Sham Comparator
    Arm Description
    patient will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
    Intervention Type
    Drug
    Intervention Name(s)
    Intraperitoneal instillation of ondansetron and bupivacaine
    Other Intervention Name(s)
    Intraperitoneal instillation of zofran and marcaine
    Intervention Description
    The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous ondansetron and intraperitoneal instillation of bupivacaine
    Other Intervention Name(s)
    Intravenous zofran and intraperitoneal instillation of marcaine
    Intervention Description
    The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
    Intervention Type
    Drug
    Intervention Name(s)
    Intraperitoneal instillation of bupivacaine
    Other Intervention Name(s)
    Intraperitoneal instillation of marcaine
    Intervention Description
    The aim is to detect effect of intraperitoneal instillation of bupivacaine
    Primary Outcome Measure Information:
    Title
    measure incidence and severity of postoperative nausea and vomiting
    Description
    using Rohdes Index of Nausea, Vomiting, and Retching it is questionnaire of 8 items with minimum score =0 and maximum score =4 for each item.
    Time Frame
    24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    measure total numbers of rescue antiemetic
    Description
    patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately
    Time Frame
    all over 24 hours postoperative.
    Title
    Duration of hospital stay
    Description
    time from PACU discharge till time to discharge home
    Time Frame
    24 hours to 72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent from the patient. Age: 21-45 years old. Both sex. Physical status: ASA 1& II. BMI = (25-35 kg/m2). Type of operation: elective laparoscopic gynecological surgeries. Exclusion Criteria: Altered mental state. Patients with known history of allergy to the study drugs. Advanced hepatic, renal, cardiovascular, and respiratory diseases. Patients with chronic pain received NSAID or opioid during previous two weeks. Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs