Cesarean Section; ShiveringNCT03356899
Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.
A study testing Low dose bupivacaine 0.5% (8mg) and High dose bupivacaine 0.5% (10mg) in people with Cesarean Section; Shivering, run by Menoufia University at 1 site in Egypt.
Trial summary
Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Read more about this study
- Who is it for?
- Ages 22 to 35 years, women only
- Conditions the study is for
- Cesarean Section; Shivering
- What is being tested?
- Low dose bupivacaine 0.5% (8mg) and High dose bupivacaine 0.5% (10mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2017to 29 Sep 2018
- 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 22 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.
Who cannot join
- Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?
Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.
Read the detailed description
After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.
The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).
Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.
The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.
- Conditions
- Cesarean Section; Shivering
- Being tested
- Low dose bupivacaine 0.5% (8mg), High dose bupivacaine 0.5% (10mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose bupivacaine 0.5% (8mg)Drug
Also called Bupivacaine for spinal anaesthesia.
8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml
High dose bupivacaine 0.5% (10mg)Drug
Also called Bupivacaine for spinal anaesthesia
10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5
| Study group | Role | What they receive |
|---|---|---|
| Low dose bupivacaine 0.5% (8mg) | Active comparator | Bupivacaine 0.5% for spinal anesthesia Receives: Drug: Low dose bupivacaine 0.5% (8mg) |
| High dose bupivacaine 0.5% (10mg) | Active comparator | Bupivacaine 0.5% for spinal anesthesia Receives: Drug: High dose bupivacaine 0.5% (10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering score
Shivering score is a graded score using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalised movement; and 4, shivering involving the movement of the whole body.
Measured: Peri-operatively
Secondary outcomes (2)
Mean arterial blood pressure (mmHg)
Mean arterial blood pressure reading
Measured: Peri-operatively
Heart rate (beat/minute)
The number of hear beats per minute
Measured: Peri-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start30 Dec 2017
- Primary completion29 Aug 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; ShiveringStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
- Investigators
- Ezzeldin Ibrahim, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356899
- Sponsor's protocol ID
- MenoufiaU2015/2
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?
- ClinicalTrials.gov ID
- NCT03356899
- Acronym / sponsor ID
- MenoufiaU2015/2
- Conditions
- Cesarean Section; Shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 29 Nov 2017 (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.
Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.
Detailed description
After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.
The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).
Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.
The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose bupivacaine 0.5% (8mg) | Active comparator | Drug: Low dose bupivacaine 0.5% (8mg)Bupivacaine 0.5% for spinal anesthesia |
| High dose bupivacaine 0.5% (10mg) | Active comparator | Drug: High dose bupivacaine 0.5% (10mg)Bupivacaine 0.5% for spinal anesthesia |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.
Key exclusion criteria (1 listed)
- Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.
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 |
|---|---|---|
| Low dose bupivacaine 0.5% (8mg)Also: Bupivacaine for spinal anaesthesia.8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml | Drug | Low dose bupivacaine 0.5% (8mg) |
| High dose bupivacaine 0.5% (10mg)Also: Bupivacaine for spinal anaesthesia10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5 | Drug | High dose bupivacaine 0.5% (10mg) |
Primary outcome
Shivering score
Time frame: Peri-operatively
Shivering score is a graded score using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalised movement; and 4, shivering involving the movement of the whole body.
2 secondary outcomes
Mean arterial blood pressure (mmHg)
Time frame: Peri-operatively
Heart rate (beat/minute)
Time frame: Peri-operatively
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 30 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section; Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
Recruiting
Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon
Hypothermia, Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Not yet recruitingPhase 4
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal 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.
Ezzeldin Ibrahim, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose bupivacaine 0.5% (8mg) and High dose bupivacaine 0.5% (10mg) in people with Cesarean Section; Shivering, run by Menoufia 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 1 inclusion and 1 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 30 Apr 2019. 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.
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: Peri-operatively). 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 30 Apr 2019.