Clinical trial NCT05317611: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: ondansetron
intraperitoneal instillation
laparoscopic gynecological surgeries
postoperative nausea and vomiting
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-04-08
Enrollment: 63
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient.
* 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:

* Altered mental state.
* 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.

Primary outcomes:
measure: measure incidence of postoperative nausea and vomiting
timeFrame: 24 hours postoperative
measure: measure severity of postoperative nausea and vomiting
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: measure total numbers of rescue antiemetic
timeFrame: all over 24 hours postoperative.
measure: Duration of hospital stay
timeFrame: 24 hours to 72 hours
measure: postoperative pain by Numerical Rating Scale
timeFrame: 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative
measure: total dose of rescue analgesia postoperative
timeFrame: 24 hours postoperative
measure: Patient satisfaction
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: El sharkia
country: Egypt
facility: faculty of human medicine, Zagazig university hospitals
Study officials:
References: