Postspinal ShiveringNCT06762860
Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.
A study testing Dexmedetomidine and Granisetron in people with Postspinal Shivering, run by Minia University at 1 site in Egypt.
Trial summary
The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postspinal Shivering
- What is being tested?
- Dexmedetomidine and Granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 28 Feb 2025
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients scheduled for cesarean section under spinal anesthesia.
- age : (20-45) years old.
- American Society of Anesthesia (ASA) physical status I, II.
Who cannot join
- Patient refusal.
- Contraindication to spinal anesthesia.
- BMI > 35 kg/m².
- Impaired renal, hepatic and cardiac function.
- Thyroid disease.
- Body temperature >38 °C or < 36.5 °C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravenous Granisetron Versus Intravenous Dexmedetomidine on Shivering Following Spinal Anesthesia in the Cesarean Section. a Randomized Controlled Comparative Trial .
The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.
Read the detailed description
Study groups:
Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.
- Conditions
- Postspinal Shivering
- Being tested
- Dexmedetomidine, Granisetron, Placebo
- Keywords
- shivering after spinal anesthesia in cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
label sticker
GranisetronDrug
label sticker
PlaceboOther
label sticker
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Patients in this group will receive (0.3 ug/kg) intravenous dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. Receives: Drug: Dexmedetomidine |
| Granisetron Group | Active comparator | Patients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord. Receives: Drug: Granisetron |
| Control Group | Placebo comparator | Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of post spinal shivering.
-The Shivering will be graded on a scale Tsai and Chu [Tsai et al .,2001] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body.
Measured: every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours
Secondary outcomes (3)
change in the basal axillary temperature.
Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs.
Measured: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively
change in the basal mean arterial blood pressure
Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs.
Measured: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Change in the basal heart rate
Change in the heart rate of the patient after administration of tested drugs (beat per minute)
Measured: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postspinal ShiveringStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group). Group D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. Group G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Mamdouh, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762860
- Sponsor's protocol ID
- postspinal shivering
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Jan 2025
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Granisetron Versus Intravenous Dexmedetomidine on Shivering Following Spinal Anesthesia in the Cesarean Section. a Randomized Controlled Comparative Trial .
- ClinicalTrials.gov ID
- NCT06762860
- Acronym / sponsor ID
- postspinal shivering
- Conditions
- Postspinal Shivering
- Keywords
- shivering after spinal anesthesia in cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.
Detailed description
Study groups:
Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group). Group D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. Group G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: DexmedetomidinePatients in this group will receive (0.3 ug/kg) intravenous dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. |
| Granisetron Group | Active comparator | Drug: GranisetronPatients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord. |
| Control Group | Placebo comparator | Other: PlaceboPatients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients scheduled for cesarean section under spinal anesthesia.
- age : (20-45) years old.
- American Society of Anesthesia (ASA) physical status I, II.
Key exclusion criteria (6 listed)
- Patient refusal.
- Contraindication to spinal anesthesia.
- BMI > 35 kg/m².
- Impaired renal, hepatic and cardiac function.
- Thyroid disease.
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 |
|---|---|---|
| Dexmedetomidinelabel sticker | Drug | Dexmedetomidine Group |
| Granisetronlabel sticker | Drug | Granisetron Group |
| Placebolabel sticker | Other | Control Group |
Primary outcome
The incidence and severity of post spinal shivering.
Time frame: every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours
-The Shivering will be graded on a scale Tsai and Chu [Tsai et al .,2001] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body.
3 secondary outcomes
change in the basal axillary temperature.
Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively
change in the basal mean arterial blood pressure
Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Change in the basal heart rate
Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Granisetron in people with Postspinal Shivering, run by Minia 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jan 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. 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.
Are results available for this study?
Results are not available in the source record.
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 and severity of post spinal shivering. (time frame: every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours). 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 9 Jan 2025.