Post Spinal ShiveringPhase 1NCT06318546
Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section
A Phase 1 study testing Dexmedetomidine Injection [Precedex],,, and Fentanyl in people with Post Spinal Shivering, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Shivering
- What is being tested?
- Dexmedetomidine Injection [Precedex],,, and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 31 Aug 2024
- Phase
- Phase 1
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • ASA I or ASA II patients Scheduled for CS under spinal anaesthesia.
- Age 20-35 years.
- Height ≤165 cm.
- BMI ≤40.
- Procedure duration ≤ 90 minutes.
Who cannot join
- • Patients with known neurologic and psychiatric illness.
- Contraindications for spinal anaesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
- Spine abnormalities.
- Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
- Allergy to any of the drugs used in the study.
- Toxemia of pregnancy or hypertension with pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section
The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section
Read the detailed description
A.Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.
B.Intraoperative and postoperative settings:
On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\kg.
For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.
Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%
- Conditions
- Post Spinal Shivering
- Being tested
- Dexmedetomidine Injection [Precedex],,,, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex],,,Drug
Also called Precedex
patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
FentanylDrug
will be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine Receives: Drug: Fentanyl |
| Dexmedetomidine | Active comparator | This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine Receives: Drug: Dexmedetomidine Injection [Precedex],,, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post spinal shivering
will be observed following spinal anaesthesia and thereafter for 3 hours. It will be graded by a blinded observer during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan [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]. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby. Positive shivering or lower grade shivering will be treated with an IV bolus of meperidine (0.5 mg/kg)
Measured: From injection to 3 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal ShiveringStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama M Ragab, M.B.B.CH, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318546
- Sponsor's protocol ID
- FMASU MS59/2024
- Status last verified
- Feb 2024
- First submitted
- 13 Mar 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All dana will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT06318546
- Acronym / sponsor ID
- FMASU MS59/2024
- Conditions
- Post Spinal Shivering
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Mar 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.
The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section
Detailed description
A.Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.
B.Intraoperative and postoperative settings:
On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\kg.
For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.
Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: FentanylThis group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine Injection [Precedex],,,This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • ASA I or ASA II patients Scheduled for CS under spinal anaesthesia.
Key exclusion criteria (6 listed)
- • Patients with known neurologic and psychiatric illness.
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex],,,Also: Precedexpatients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5% | Drug | Dexmedetomidine |
| Fentanylwill be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5% | Drug | Control |
Primary outcome
Post spinal shivering
Time frame: From injection to 3 hours post operative
will be observed following spinal anaesthesia and thereafter for 3 hours. It will be graded by a blinded observer during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan [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]. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby. Positive shivering or lower grade shivering will be treated with an IV bolus of meperidine (0.5 mg/kg)
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 5 Nov 2024.
- Individual participant dataSharing planned: Yes. All dana will be shared once study is completed
Related trials for Post Spinal Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
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Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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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
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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.
Osama M Ragab, M.B.B.CH principal investigator
Anesthesia resident 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 1 study testing Dexmedetomidine Injection [Precedex],,, and Fentanyl in people with Post Spinal Shivering, 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 5 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: finished, as of the sponsor's last update on 5 Nov 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Post spinal shivering (time frame: From injection to 3 hours post operative). 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 5 Nov 2024.