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Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy

NCT04891484 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-09-26

No results posted yet for this study

Summary

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 .

Conditions

  • Percutaneous Nephrolithotomy

Interventions

DRUG

Ondansetron group

patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia

DRUG

Saline group

patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mahmoud M Othman, MD · Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-04-01
Completion
2022-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891484 on ClinicalTrials.gov