Nausea and Vomiting, Postoperative Clinical Trial
Official title:
The Effect of Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting in Ureteroscopic Procedures Under Spinal Anesthesia
Verified date | August 2023 |
Source | Cairo University |
Contact | BESHOY ATEF |
Phone | 01220703346 |
beshoyatef01[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Post-operative nausea and vomiting are a leading cause of recovery room delays and low patient satisfaction. Complications such as suture line tension, wound hemorrhage and dehiscence, elevated intracranial pressure, pulmonary aspiration, dehydration, and electrolyte imbalance have been linked to nausea and vomiting. Many studies were done to explore the effects of propofol and dexmedetomidine on the incidence of post operative nausea and vomiting (PONV). In this study, we will compare propofol infusion to dexmedetomidine infusion on the incidence of PONV in patients undergoing ureteroscopic procedures under spinal anesthesia in the age group from 18 to 60 years with more than one risk factor for PONV (female, history of PONV, non-smoking).
Status | Recruiting |
Enrollment | 45 |
Est. completion date | February 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients aged 18 to 60 years - ASA physical status I-II - Scheduled for ureteroscopic procedure - With more than one Risk factor for PONV (female, history of PONV, non-smoking). Exclusion Criteria: - Patients with contraindications for spinal anesthesia including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure. - History of allergy or hypersensitivity to propofol or dexmedetomidine. - Gastrointestinal diseases e.g. gastroenteritis and gastric ulcers, ear diseases e.g. infections of middle and inner ear, liver cirrhosis. - Those who have received antiemetic drugs within 48 hours before surgery. - Operations lasting more than two hours. - The patient's unwillingness. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasralaini Medical School | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | primary outcome | Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia | 6 hours | |
Secondary | secondry outcome | heart rate | 2 hours | |
Secondary | tertiary outcome | arterial blood pressure | 2 hours |
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