Anesthesia; Adverse Effect, Spinal and EpiduralPhase 4NCT06513806
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
A Phase 4 study testing Granisetron 1 Mg/mL Intravenous Solution and Pethidin in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by Ain Shams University at 1 site in Egypt.
Trial summary
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural
- What is being tested?
- Granisetron 1 Mg/mL Intravenous Solution and Pethidin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 28 Sep 2024
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.
- Age 18 - 45
Who cannot join
- Inability to provide informed consent.
- Previous allergies or sensitivities to granisetron or pethidine.
- Current use of medications that may interact with granisetron or pethidine.
- Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.
- Patients who are too short (<140 cm) or too tall (>190 cm)
Trial locations and contacts
1 site in 1 country.
About this study
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Read the detailed description
Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.
Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.
Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)
If shivering occurs the degree of Shivering will be classified as:
- 0: No shivering
- 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
- 2: Visible tremor involving more than one muscle group
- 3: Gross muscular activity involving the entire body
- Being tested
- Granisetron 1 Mg/mL Intravenous Solution, Pethidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron 1 Mg/mL Intravenous SolutionDrug
will receive granisetron 3 mg iv bolus
PethidinDrug
will receive pethidine 25 mg iv bolus
| Study group | Role | What they receive |
|---|---|---|
| granisetron group | Active comparator | will receive granisetron 3 mg iv bolus Receives: Drug: Granisetron 1 Mg/mL Intravenous Solution |
| pethidine group | Active comparator | will receive pethidine 25 mg iv bolus Receives: Drug: Pethidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
treating post spinal shivering
If shivering occurs the degree of Shivering will be classified as:
- 0: No shivering
- 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
- 2: Visible tremor involving more than one muscle group
- 3: Gross muscular activity involving the entire body assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine
Measured: perioperatively/periprocedurally
Secondary outcomes (2)
pain assessment
pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain
Measured: 12 hours postoperative
nausea, vomiting
incidence of postoperative complications: nausea, vomiting
Measured: 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024
- Primary completion25 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdou, Ain Shams University
- Investigators
- Ayman M Kamaly, MD, Study chair, Ain Shams UniversityDavid S Said, Msc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513806
- Sponsor's protocol ID
- FMASU MS84/2024
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
- ClinicalTrials.gov ID
- NCT06513806
- Acronym / sponsor ID
- FMASU MS84/2024
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 22 Jul 2024 (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.
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Detailed description
Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.
Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.
Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)
If shivering occurs the degree of Shivering will be classified as:
- 0: No shivering
- 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
- 2: Visible tremor involving more than one muscle group
- 3: Gross muscular activity involving the entire body
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| granisetron group | Active comparator | Drug: Granisetron 1 Mg/mL Intravenous Solutionwill receive granisetron 3 mg iv bolus |
| pethidine group | Active comparator | Drug: Pethidinwill receive pethidine 25 mg iv bolus |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.
- Age 18 - 45
Key exclusion criteria (5 listed)
- Inability to provide informed consent.
- Previous allergies or sensitivities to granisetron or pethidine.
- Current use of medications that may interact with granisetron or pethidine.
- Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.
- Patients who are too short (<140 cm) or too tall (>190 cm)
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 |
|---|---|---|
| Granisetron 1 Mg/mL Intravenous Solutionwill receive granisetron 3 mg iv bolus | Drug | granisetron group |
| Pethidinwill receive pethidine 25 mg iv bolus | Drug | pethidine group |
Primary outcome
treating post spinal shivering
Time frame: perioperatively/periprocedurally
If shivering occurs the degree of Shivering will be classified as: * 0: No shivering * 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms * 2: Visible tremor involving more than one muscle group * 3: Gross muscular activity involving the entire body assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine
2 secondary outcomes
pain assessment
Time frame: 12 hours postoperative
nausea, vomiting
Time frame: 12 hours postoperative
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 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Ayman M Kamaly, MD study chair
Ain Shams University
David S Said, Msc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granisetron 1 Mg/mL Intravenous Solution and Pethidin in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by Ain Shams 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 5 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 2 Oct 2025. 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
treating post spinal shivering (time frame: perioperatively/periprocedurally). 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 2 Oct 2025.