Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy
Primary Purpose
Percutaneous Nephrolithotomy
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ondansetron group
Saline group
Sponsored by
About this trial
This is an interventional treatment trial for Percutaneous Nephrolithotomy focused on measuring Ondansetron, hypotension,vasopressor
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for PCNL surgery.
- ASA classification I or II
Exclusion Criteria:
- Patient refusal
- Contraindication to spinal anesthesia.
- Known allergy to Ondansetron.
- Uncontrolled hypertensive patient.
- Ischemic heart diseases.
- Moderate to severe stenotic valve lesion.
- Atrial fibrillation.
Sites / Locations
- Urology and nephrology center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ondansetron group
Control group
Arm Description
Group O :patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
The duration and number of hypotension episodes
The duration of each hypotension episode
The need of vasopressors (ephedrine and noradrenaline) .
The need and the dose of vasopressors (ephedrine and noradrenaline) .
The incidence of bradycardia Intraoperative
The incidence of bradycardia Intraoperative
The incidence of perioperative nausea and vomiting
The incidence of perioperative nausea and vomiting
The incidence of perioperative shivering
The incidence of perioperative shivering
The incidence of perioperative pruritus
The incidence of perioperative pruritus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04891484
Brief Title
Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy
Official Title
Effect of Ondansetron on Spinal-induced Hypotension by Using Bupivacaine -Dexmedetomidine Mixture Intrathecally for Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 .
Detailed Description
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;
Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Group O:patients will be injected with 4mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia Spinal anesthesia will be delivered in the sitting position under complete aseptic condition using 25-gauge spinal needle (quinckle type), the needle will be advanced at level L 4-5 or L 3 - 4. After a clear flow of CSF, 3ml 0.5 % hyperbaric bupivacaine (15mg)will be injected followed by 5 Mcg dexmedetomidine in insulin syringe diluted to 1ml .After anesthesia, patients will be positioned supine immediately, sensory level will be assessed each 2 minutes by pinprick test, a sensory block at T4-6 will be considered sufficient to start surgery.o BP, HR and oxygen saturation will be recorded every 5 minutes for first 30 minutes then every 15 minutes till the end of surgery. Hypotension will be defined as a decrease blood pressure more than 20% of basal BP or decrease systolic than 90 mmHg and will be treated with IV ephedrine (5mg bolus). Bradycardia will be defined as heart rate less than 50 beat / min and will be treated with IV atropine (0.5mg).The maximum level of sensory block will be assessed every 2 minutes till reaching maximum level of sensory block by pin prick test or cold sensation using alcohol swab.The incidence of ECG changes(dysrhythmia, ST changes).The incidence of pruritus.The incidence of nausea and /or vomiting.Postoperative data( HR, BP, SPo2) will be measured every 15 minutes for 2 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Nephrolithotomy
Keywords
Ondansetron, hypotension,vasopressor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
InvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron group
Arm Type
Experimental
Arm Description
Group O :patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron group
Intervention Description
patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Saline group
Intervention Description
patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Primary Outcome Measure Information:
Title
The incidence of hypotension during spinal anesthesia for percutaneous nephrolithotomy
Description
The incidence of hypotension with mean pressure below 60 mmhg during spinal anesthesia for PCNL
Time Frame
perioperative time for two hours postoperatively
Secondary Outcome Measure Information:
Title
The severity of hypotension
Description
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
Title
The duration and number of hypotension episodes
Description
The duration of each hypotension episode
Time Frame
perioperative time for two hours postoperatively
Title
The need of vasopressors (ephedrine and noradrenaline) .
Description
The need and the dose of vasopressors (ephedrine and noradrenaline) .
Time Frame
perioperative time for two hours postoperatively
Title
The incidence of bradycardia Intraoperative
Description
The incidence of bradycardia Intraoperative
Time Frame
perioperative time for two hours postoperatively
Title
The incidence of perioperative nausea and vomiting
Description
The incidence of perioperative nausea and vomiting
Time Frame
perioperative time for two hours postoperatively
Title
The incidence of perioperative shivering
Description
The incidence of perioperative shivering
Time Frame
perioperative time for two hours postoperatively
Title
The incidence of perioperative pruritus
Description
The incidence of perioperative pruritus
Time Frame
perioperative time for two hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for PCNL surgery.
ASA classification I or II
Exclusion Criteria:
Patient refusal
Contraindication to spinal anesthesia.
Known allergy to Ondansetron.
Uncontrolled hypertensive patient.
Ischemic heart diseases.
Moderate to severe stenotic valve lesion.
Atrial fibrillation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud M Othman, MD
Organizational Affiliation
Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and nephrology center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
050
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy
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