Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy

NCT04891484 | Completed Early Phase 1 DMC

• 1 other identifier: MS.20.09.1248
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ondansetron, hypotension,vasopressor

Outcome Measures

Primary Outcomes (1)

• 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

  perioperative time for two hours postoperatively

Secondary Outcomes (7)

• The severity of hypotension

  perioperative time for two hours postoperatively

• The duration and number of hypotension episodes

  perioperative time for two hours postoperatively

• The need of vasopressors (ephedrine and noradrenaline) .

  perioperative time for two hours postoperatively

• The incidence of bradycardia Intraoperative

  perioperative time for two hours postoperatively

• The incidence of perioperative nausea and vomiting

  perioperative time for two hours postoperatively

Study Arms (2)

Ondansetron group

EXPERIMENTAL

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

Drug: Ondansetron group

Control group

PLACEBO COMPARATOR

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

Drug: Saline group

Interventions

Ondansetron group DRUG

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

Ondansetron group

Saline group DRUG

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

Control group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for PCNL surgery.
• ASA classification I or II

You may not qualify if:

• Patient refusal
• Contraindication to spinal anesthesia.
• Known allergy to Ondansetron.
• Uncontrolled hypertensive patient.
• Ischemic heart diseases.
• Moderate to severe stenotic valve lesion.
• Atrial fibrillation.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mahmoud M Othman, MD

  Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and surgical Intensive care

Model Details: Two groups were enrolled in this study. They will randomized into two groups •Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia •Group O:patient swill be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 18, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)