Prevention
Conditions
Keywords
ondansetron, intraperitoneal instillation, laparoscopic gynecological surgeries, postoperative nausea and vomiting
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.
Interventions
DRUGIntraperitoneal instillation of ondansetron and bupivacaine
The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting
DRUGIntravenous ondansetron and intraperitoneal instillation of bupivacaine
The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
The aim is to detect effect of intraperitoneal instillation of bupivacaine
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measure incidence of postoperative nausea and vomiting | 24 hours postoperative | The number of patient suffering from postoperative nausea and vomiting in each group |
| measure severity of postoperative nausea and vomiting | 24 hours postoperative | Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS) 1. \*Frequency of Nausea:\* * 0: None * 1: Occasionally (1-2 times a day) * 2: Frequently (3-4 times a day) * 3: Constantly (more than 4 times a day) 2. \*Frequency of Vomiting:\* * 0: None * 1: Once a day * 2: 2-3 times a day * 3: More than 3 times a day 3. \*Impact on Daily Activities:\* * 0: No impact * 1: Mild impact (able to perform most activities) * 2: Moderate impact (some activities limited) * 3: Severe impact (most activities limited) #Scoring * \*Total Score:\* Sum of scores from all 3 items. * \*Interpretation:\* Higher total scores indicate a greater impact of nausea and vomiting on the patient recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain by Numerical Rating Scale | 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative | 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain) |
| measure total numbers of rescue antiemetic | all over 24 hours postoperative. | patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately |
| Patient satisfaction | 24 hours postoperative | degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia) |
| total dose of rescue analgesia postoperative | 24 hours postoperative | total dose of diclofenac as rescue analgesia postoperative |
| Duration of hospital stay | 24 hours to 72 hours | time from PACU discharge till time to discharge home |
Countries
Egypt
Outcome results
None listed