Postoperative Nausea and Vomiting (PONV)
Conditions
Brief summary
Postoperative nausea and vomiting (PONV) remain common and distressing complications following laparoscopic cholecystectomy, particularly in female patients. This randomized interventional study aims to evaluate the effectiveness of preoperative granisetron when combined with either dexamethasone or metoclopramide in preventing PONV. The study compares the incidence and severity of nausea and vomiting, as well as the need for rescue antiemetic therapy, among female patients undergoing laparoscopic cholecystectomy under general anesthesia.
Detailed description
Postoperative nausea and vomiting (PONV) are among the most frequent complications after laparoscopic cholecystectomy and are associated with patient discomfort, delayed recovery, prolonged hospital stay, and decreased patient satisfaction. Female gender, laparoscopic surgery, and the use of general anesthesia are well-recognized risk factors for PONV. Granisetron, a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, has proven efficacy in the prevention of PONV. Combining granisetron with other antiemetic agents that have different mechanisms of action, such as dexamethasone or metoclopramide, may enhance its antiemetic effect through a multimodal approach. This prospective randomized interventional study is designed to compare the efficacy of preoperative granisetron combined with dexamethasone versus granisetron combined with metoclopramide in preventing PONV in female patients undergoing laparoscopic cholecystectomy under general anesthesia. Eligible patients will be randomly allocated into two groups to receive either granisetron with dexamethasone or granisetron with metoclopramide prior to induction of anesthesia. The primary outcome measure will be the incidence of postoperative nausea and vomiting within the first 24 hours after surgery. Secondary outcomes will include the severity of nausea, frequency of vomiting episodes, requirement for rescue antiemetic medications, and the occurrence of any adverse effects related to the study drugs. The results of this study aim to identify the more effective granisetron-based combination for PONV prophylaxis in this high-risk population, potentially contributing to improved postoperative care and patient satisfaction following laparoscopic cholecystectomy.
Interventions
DRUGGranisetron
Granisetron will be administered intravenously preoperatively for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind design with identical preparation and administration of study medications to maintain blinding.
Intervention model description
This is a randomized, double-blind, parallel-group clinical trial evaluating the preventive effect of granisetron plus dexamethasone versus granisetron plus metoclopramide on the prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- 1- Adult female. 2- (ASA I-II), aged 18-60 years. 3- Non smoker. 4- Scheduled for elective laparoscopic cholecystectomy under general anesthesia. 5- Use of intraoperative opioid analgesics.
Exclusion criteria
* 1- History of hypersensitivity to study drugs. 2- Chronic antiemetic. 3- Antidepressant use. 4- Gastrointestinal disease. 5- Pregnancy/lactation. 6- Severe hepatic/renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) | 0-24 hours postoperatively | The incidence of postoperative nausea and vomiting (PONV) will be recorded and compared between the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative nausea | 0-24 hours postoperatively | Severity of nausea will be assessed using a visual analog scale (VAS) ranging from 0 to 10. |
| Number of vomiting or retching episodes | 0-24 hours postoperatively | The total number of vomiting or retching episodes will be recorded for each patient. |
| Requirement for rescue antiemetic medication | 0-24 hours postoperatively | The need for rescue antiemetic medication will be recorded during the postoperative period. |
| Patient satisfaction score | 0-24 hours postoperatively | Patient satisfaction with postoperative nausea and vomiting management will be assessed using a satisfaction scoring system. |
| Incidence of adverse effects | 0-24 hours postoperatively | The incidence of adverse effects including headache, dizziness, and extrapyramidal symptoms will be recorded. |
Contacts
CONTACTAmir Mohamed Abd El Halim Mokhimar
Outcome results
None listed