Post Spinal Anesthesia ShiveringPhase 2NCT06031090
Clonidine Versus Granisetron for Shivering Prevension
A Phase 2 study testing Clonidine Injection, Granisetron Injection and Normal Saline 10 mL Injection in people with Post Spinal Anesthesia Shivering, run by Zagazig University at 1 site in Egypt.
Trial summary
Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Anesthesia Shivering
- What is being tested?
- Clonidine Injection, Granisetron Injection and Normal Saline 10 mL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2023to 30 Oct 2023
- Phase
- Phase 2
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Heba M Fathi
Zagazig, 44519
Heba M Fathi, M.D, 002-01000143938, heba_elgendi@yahoo.com
About this study
Official title: Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section
Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption
Read the detailed description
Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.
Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.
We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.
- Conditions
- Post Spinal Anesthesia Shivering
- Being tested
- Clonidine Injection, Granisetron Injection, Normal Saline 10 mL Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine InjectionDrug
intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
Granisetron InjectionDrug
intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.
Normal Saline 10 mL InjectionDrug
intravenous 10 ml normal saline 20 minutes before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Cl (clonidine group) | Active comparator | will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia Receives: Drug: Clonidine Injection |
| Group G (granisetron group) | Active comparator | will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia. Receives: Drug: Granisetron Injection |
| Group C (control group) | Placebo comparator | will be given intravenous10ml normal saline 20 minutes before spinal anesthesia Receives: Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Shivering
- Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body
Measured: Procedure (through out the period of spinal anesthesia)
Secondary outcomes (4)
core body temperature
Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy).
Measured: Procedure (preoperative as base and through out the period of spinal anesthesia)
Maternal Heart rate
beats/minute
Measured: Procedure (preoperative as base and through out the period of spinal anesthesia)
baby APGAR score
Measured: 1 minutes and 5 minutes post natal
maternal blood presure
mmhg
Measured: Procedure (preoperative as base and through out the period of spinal anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start5 Mar 2023
- Primary completion5 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anesthesia ShiveringStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba M Fathi, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031090
- Sponsor's protocol ID
- zu-IRB#10415/26-2-2023
- Status last verified
- Sep 2023
- First submitted
- 27 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section
- ClinicalTrials.gov ID
- NCT06031090
- Acronym / sponsor ID
- zu-IRB#10415/26-2-2023
- Conditions
- Post Spinal Anesthesia Shivering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 5 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 11 Sep 2023 (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.
Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption
Detailed description
Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.
Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.
We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Cl (clonidine group) | Active comparator | Drug: Clonidine Injectionwill be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia |
| Group G (granisetron group) | Active comparator | Drug: Granisetron Injectionwill be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia. |
| Group C (control group) | Placebo comparator | Drug: Normal Saline 10 mL Injectionwill be given intravenous10ml normal saline 20 minutes before spinal anesthesia |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus
- -
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 |
|---|---|---|
| Clonidine Injectionintravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia | Drug | Group Cl (clonidine group) |
| Granisetron Injectionintravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia. | Drug | Group G (granisetron group) |
| Normal Saline 10 mL Injectionintravenous 10 ml normal saline 20 minutes before spinal anesthesia | Drug | Group C (control group) |
Primary outcome
Incidence of Shivering
Time frame: Procedure (through out the period of spinal anesthesia)
• Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body
4 secondary outcomes
core body temperature
Time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
Maternal Heart rate
Time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
baby APGAR score
Time frame: 1 minutes and 5 minutes post natal
maternal blood presure
Time frame: Procedure (preoperative as base and through out the period of spinal anesthesia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia
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The Effect of Different Doses of Dexamethasone on Post Spinal Anesthesia Shivering
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine Injection, Granisetron Injection and Normal Saline 10 mL Injection in people with Post Spinal Anesthesia Shivering, run by Zagazig 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 0 inclusion and 2 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 11 Sep 2023. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Heba M Fathi, M.D (00201000143938, heba_elgendi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Shivering (time frame: Procedure (through out the period of spinal anesthesia)). 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 11 Sep 2023; AzTrials last refreshed its copy on 3 Nov 2026.