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

Prevention Clinical Trial

Official title:

Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05317611
• Other study ID #: 9286-23-2-2022
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 1, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: April 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: October 15, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prevention
• Vomiting

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours postoperative
Secondary	measure total numbers of rescue antiemetic	patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately	all over 24 hours postoperative.
Secondary	Duration of hospital stay	time from PACU discharge till time to discharge home	24 hours to 72 hours