Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.
NCT ID: NCT05317611
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2022-07-01
2025-01-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intraperitoneal instillation of ondansetron and bupivacaine (group A)
Patients will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % 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.
Intraperitoneal instillation of ondansetron and bupivacaine
The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting
Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)
Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
Intravenous ondansetron and intraperitoneal instillation of bupivacaine
The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
Intraperitoneal instillation of bupivacaine (group C)
patient will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.
Intraperitoneal instillation of bupivacaine
The aim is to detect effect of intraperitoneal instillation of bupivacaine
Interventions
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Intraperitoneal instillation of ondansetron and bupivacaine
The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting
Intravenous ondansetron and intraperitoneal instillation of bupivacaine
The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
Intraperitoneal instillation of bupivacaine
The aim is to detect effect of intraperitoneal instillation of bupivacaine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 21-60 years old.
* female patients
* Physical status: ASA 1\& II.
* BMI = ≤ 35 kg/m2).
* Type of operation: elective laparoscopic gynecological surgeries.
Exclusion Criteria
* Patients with known history of allergy to the study drugs.
* hepatic, renal impairment or disease , 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.
21 Years
60 Years
FEMALE
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Dina Abdelhameed Elsadek Salem
principle investigator
Locations
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faculty of human medicine, Zagazig university hospitals
El Sharkia, , Egypt
Countries
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Other Identifiers
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9286-23-2-2022
Identifier Type: -
Identifier Source: org_study_id
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