Spinal Induced ShiveringPhase 2NCT02588547
Prevention of Spinal Induced Shivering During CS
A Phase 2 study testing Granisetron and Sodium chloride in people with Spinal Induced Shivering, run by Assiut University at 1 site in Egypt.
Trial summary
This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Spinal Induced Shivering
- What is being tested?
- Granisetron and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to May 2017
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women at term,
- ASA status I or II (American Society of Anesthesiologists) physical status class I-II,
- low-risk cesarean section,
- Scheduled for the spinal anesthesia
Who cannot join
- Pregnant women in labor
- Patients who have the body temperature over 37.3 or less than 37 celsius degree
- Known allergies to the study drugs
- Contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study
This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.
Read the detailed description
The study will includes four groups as follows:
- Granisetron1 group: women will receive 1mg IV granisetron
- Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
- Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received.
Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.
- Conditions
- Spinal Induced Shivering
- Being tested
- Granisetron, Sodium chloride
- Keywords
- Shivering, Granisetron, Spinal, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranisetronDrug
Also called Kytril ampule 3mg/3ml IV (Roche)
IV granisetron 1 mg before spinal anethesia
GranisetronDrug
Also called Kytril ampule 3mg/3ml IV (Roche)
IV granisetron 0.7 mg before spinal anethesia
Sodium chlorideDrug
Also called 0.9 Sodium chloride
IV 2 ml 0.9 sodium chloride before spinal anethesia
| Study group | Role | What they receive |
|---|---|---|
| Granisetron 1 | Active comparator | Intravenous granisetron 1 mg Receives: Drug: Granisetron |
| Granisetron 0.7 | Active comparator | Intravenous granisetron 0.7 mg Receives: Drug: Granisetron |
| Placebo | Placebo comparator | intravenous 0.9% Sodium chloride (2 ml) Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
shivering score
Measured: 180 min (immediately before the block till 180 min after the block)
Secondary outcomes (3)
non invasive blood pressure
Measured: 90 min (immediately before the block till 90 min after the block)
heart rate
Measured: 90 min (immediately before the block till 90 min after the block)
core temperature
Measured: 90 min (immediately before the block till 90 min after the block)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Induced ShiveringStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588547
- Sponsor's protocol ID
- SM102015
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdel-Ghaffar HS, Moeen SM. Prophylactic granisetron for post-spinal anesthesia shivering in cesarean section: A randomized controlled clinical study. Acta Anaesthesiol Scand. 2019 Mar;63(3):381-388. doi: 10.1111/aas.13084. Epub 2018 Feb 8.
PubMed 29424008
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study
- ClinicalTrials.gov ID
- NCT02588547
- Acronym / sponsor ID
- SM102015
- Conditions
- Spinal Induced Shivering
- Keywords
- Shivering, Granisetron, Spinal, Cesarean section
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.
Detailed description
The study will includes four groups as follows:
- Granisetron1 group: women will receive 1mg IV granisetron
- Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
- Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received.
Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Granisetron 1 | Active comparator | Drug: GranisetronIntravenous granisetron 1 mg |
| Granisetron 0.7 | Active comparator | Drug: GranisetronIntravenous granisetron 0.7 mg |
| Placebo | Placebo comparator | Drug: Sodium chlorideintravenous 0.9% Sodium chloride (2 ml) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant women at term,
- ASA status I or II (American Society of Anesthesiologists) physical status class I-II,
- low-risk cesarean section,
- Scheduled for the spinal anesthesia
Key exclusion criteria (4 listed)
- Pregnant women in labor
- Patients who have the body temperature over 37.3 or less than 37 celsius degree
- Known allergies to the study drugs
- Contraindication to spinal anesthesia
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 |
|---|---|---|
| GranisetronAlso: Kytril ampule 3mg/3ml IV (Roche)IV granisetron 1 mg before spinal anethesia | Drug | Granisetron 1 |
| GranisetronAlso: Kytril ampule 3mg/3ml IV (Roche)IV granisetron 0.7 mg before spinal anethesia | Drug | Granisetron 0.7 |
| Sodium chlorideAlso: 0.9 Sodium chlorideIV 2 ml 0.9 sodium chloride before spinal anethesia | Drug | Placebo |
Primary outcome
shivering score
Time frame: 180 min (immediately before the block till 180 min after the block)
3 secondary outcomes
non invasive blood pressure
Time frame: 90 min (immediately before the block till 90 min after the block)
heart rate
Time frame: 90 min (immediately before the block till 90 min after the block)
core temperature
Time frame: 90 min (immediately before the block till 90 min after the block)
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 17 Nov 2017.
- Derived from this study: PubMed 29424008Abdel-Ghaffar HS, Moeen SM. Prophylactic granisetron for post-spinal anesthesia shivering in cesarean section: A randomized controlled clinical study. Acta Anaesthesiol Scand. 2019 Mar;63(3):381-388. doi: 10.1111/aas.13084. Epub 2018 Feb 8.
Related trials for Spinal Induced Shivering
Active, not recruiting
Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia
Post Spinal Anesthesia Shivering
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.
Seham M Moeen, MD principal investigator
Assiut Univerisity
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 Granisetron and Sodium chloride in people with Spinal Induced Shivering, run by Assiut 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 4 inclusion and 4 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 17 Nov 2017. 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?
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?
shivering score (time frame: 180 min (immediately before the block till 180 min after the block)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588547, which also lists 1 linked publication.
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 17 Nov 2017.