Percutaneous NephrolithotomyEarly Phase 1NCT04891484
Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy
A Early Phase 1 study testing Ondansetron group and Saline group in people with Percutaneous Nephrolithotomy, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Ondansetron group and Saline group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Sep 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for PCNL surgery.
- ASA classification I or II
Who cannot join
- Patient refusal
- Contraindication to spinal anesthesia.
- Known allergy to Ondansetron.
- Uncontrolled hypertensive patient.
- Ischemic heart diseases.
- Moderate to severe stenotic valve lesion.
- Atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center
Al Mansurah, Dakahlia Governorate, 050
About this study
Official title: Effect of Ondansetron on Spinal-induced Hypotension by Using Bupivacaine -Dexmedetomidine Mixture Intrathecally for Percutaneous Nephrolithotomy
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 .
Read the 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.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Ondansetron group, Saline group
- Keywords
- Ondansetron, hypotension,vasopressor
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron groupDrug
patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
Saline groupDrug
patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron group | Experimental | Group O :patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia Receives: Drug: Ondansetron group |
| Control group | Placebo comparator | Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia Receives: Drug: Saline group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: perioperative time for two hours postoperatively
Secondary outcomes (7)
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)
Measured: perioperative time for two hours postoperatively
The duration and number of hypotension episodes
The duration of each hypotension episode
Measured: perioperative time for two hours postoperatively
The need of vasopressors (ephedrine and noradrenaline) .
The need and the dose of vasopressors (ephedrine and noradrenaline) .
Measured: perioperative time for two hours postoperatively
The incidence of bradycardia Intraoperative
The incidence of bradycardia Intraoperative
Measured: perioperative time for two hours postoperatively
The incidence of perioperative nausea and vomiting
The incidence of perioperative nausea and vomiting
Measured: perioperative time for two hours postoperatively
The incidence of perioperative shivering
The incidence of perioperative shivering
Measured: perioperative time for two hours postoperatively
The incidence of perioperative pruritus
The incidence of perioperative pruritus
Measured: perioperative time for two hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mahmoud Othman, Mansoura University
- Investigators
- Mahmoud M Othman, MD, Principal investigator, Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891484
- Sponsor's protocol ID
- MS.20.09.1248
- Status last verified
- Sep 2022
- First submitted
- 10 May 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ondansetron on Spinal-induced Hypotension by Using Bupivacaine -Dexmedetomidine Mixture Intrathecally for Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04891484
- Acronym / sponsor ID
- MS.20.09.1248
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Ondansetron, hypotension,vasopressor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ondansetron group | Experimental | Drug: Ondansetron groupGroup O :patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia |
| Control group | Placebo comparator | Drug: Saline groupGroup S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients scheduled for PCNL surgery.
- ASA classification I or II
Key exclusion criteria (7 listed)
- Patient refusal
- Contraindication to spinal anesthesia.
- Known allergy to Ondansetron.
- Uncontrolled hypertensive patient.
- Ischemic heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron grouppatients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia | Drug | Ondansetron group |
| Saline grouppatients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia | Drug | Control group |
Primary outcome
The incidence of hypotension during spinal anesthesia for percutaneous nephrolithotomy
Time frame: perioperative time for two hours postoperatively
The incidence of hypotension with mean pressure below 60 mmhg during spinal anesthesia for PCNL
7 secondary outcomes
The severity of hypotension
Time frame: perioperative time for two hours postoperatively
The duration and number of hypotension episodes
Time frame: perioperative time for two hours postoperatively
The need of vasopressors (ephedrine and noradrenaline) .
Time frame: perioperative time for two hours postoperatively
The incidence of bradycardia Intraoperative
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative nausea and vomiting
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative shivering
Time frame: perioperative time for two hours postoperatively
The incidence of perioperative pruritus
Time frame: perioperative time for two hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Nephrolithotomy
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Recruiting
Nephrostomy Tract Infiltration for Pain Control After PCNL
Postoperative Pain, Kidney Calculi
Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
Nephrolithiasis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud M Othman, MD principal investigator
Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ondansetron group and Saline group in people with Percutaneous Nephrolithotomy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypotension during spinal anesthesia for percutaneous nephrolithotomy (time frame: perioperative time for two hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.