An Early Phase 1 interventional study of Ondansetron group and Saline group in Percutaneous Nephrolithotomy, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by Mansoura University · Early Phase 1, Interventional, and Treatment
Percutaneous nephrolithotomy (PCNL) is the surgical standard for treating large or complex renal stones. The stones are removed by passing a small telescope through the side of the patient directly into the kidney, so the stone can be broken up and the fragments are removed .PCNL can be performed under general anesthesia or spinal anesthesia. SA has some advantage over GA, such as lower postoperative pain, lower consumption of analgesic drugs and avoidance of side effects from multiple medications used in GA.However, SA induced sympathetic block leads to a decrease in the systemic vascular resistance and subsequent drop in the arterial blood pressure. Furthermore, anesthesia for PCNL usually requires a high sensory level reaching T4,resulting in a high incidence (nearly 33%) of hypotension. Also, to meet the long duration of surgery, drugs, ;like dexmedetomidine, are added to intrathecal local anesthetics , increasing the incidence of hemodynamic instability induced by the spinal anesthesia.
Decreasing the systemic vascular resistance (SVR) and the venous return to the heart result in a reflex vasodilation, bradycardia and hypotension. This reflex is called Bezold -Jarisch reflex and is mediated by serotonin receptors (5_HT3) located on the vagus nerve and within the wall of the cardiac ventricles.
Ondansetron; an antiemetic drug used for treatment of perioperative nausea and vomiting, was investigated as a 5HT antagonist for inhibition of Bezold - Jarisch reflex. While some studies proved its efficacy in prevention of spinal anesthesia induced hypotension , other studies could not support this conclusion .
This study aims to assess the effect of Ondansetron on spinal induced hypotension when bupivacaine and dexmedetomidine are used intrathecally during spinal anesthesia for percutaneous nephrolithotomy.This prospective randomized double-blinded study will be carried out at Urology and Nephrology center, Mansoura University after approval of Institutional Research Board, Faculty of Medicine, Mansoura University. Written informed consents will be obtained from participants after explanation of the used drug and its possible consequences.
Basal readings for blood pressure, heart rate, and ECG analysis and oxygen saturation will be recorded before the start of spinal anesthesia.
Upon arrival to OR, wide bore intravenous access (20 gauge cannula) will be secured for preoperative fluid preloading (10 ml/kg ringer solution intravenously).All patients will be monitored for non-invasive blood pressure (BP), Heart rate (HR) , ECG and pulse oximetry , measurements will be recorded every 5 min for first 30 minutes then every 15 min till the end of surgery .Patients will be randomly divided into two groups, using a computer generated random table;
1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 686 interventional studies indexed under Hypotension.
Browse Hypotension studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Group O :patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
Drug: Ondansetron group
Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Drug: Saline group
patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
The incidence of hypotension during spinal anesthesia for percutaneous nephrolithotomy
The incidence of hypotension with mean pressure below 60 mmhg during spinal anesthesia for PCNL
Time frame: perioperative time for two hours postoperatively
The severity of hypotension
The severity of hypotension with mean blood pressurer either mild (less than 60 mmHg), or moderate(less than50 mmHg or severe (less than 40mmHg)
Time frame: perioperative time for two hours postoperatively
The duration and number of hypotension episodes
The duration of each hypotension episode
Time frame: perioperative time for two hours postoperatively
The need of vasopressors (ephedrine and noradrenaline) .
The need and the dose of vasopressors (ephedrine and noradrenaline) .
Time frame: perioperative time for two hours postoperatively
The incidence of bradycardia Intraoperative
The incidence of bradycardia Intraoperative
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative nausea and vomiting
The incidence of perioperative nausea and vomiting
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative shivering
The incidence of perioperative shivering
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative pruritus
The incidence of perioperative pruritus
Time frame: perioperative time for two hours postoperatively
Plan to share: No
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Ran from Apr 2021 to primary completion in Apr 2022, 12 months.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron