ChillsPhase 3NCT05481281
Comparison Of Dexmedetomidine & Ketamine For Control Of Shivering In Vaginal Hysterectomy Under Spinal Anesthesia
A Phase 3 study testing Dexmedetomidine and Ketamine in people with Chills, run by Hamdard University.
Trial summary
comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chills
- What is being tested?
- Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Jan 2023
- Phase
- Phase 3
- 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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of age 45-55 years requiring vaginal hysterectomy
- American Society of Anesthesiology (ASA) of Grade I-II
Who cannot join
- Patients unwilling or non-cooperative for spinal anesthesia
- Patients with uncontrolled hypertension, vascular or coronary disease,
- patients with increased intraocular or intracranial pressure
- Patients with known bleeding and psychiatric disorders
- Patients taking anti platelets drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia
comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.
Read the detailed description
In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.
- Conditions
- Chills
- Being tested
- Dexmedetomidine, Ketamine
- Keywords
- spinal anesthesia, vaginal hysterectomy, shivering
- Medical subject headings
- Chills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion
KetamineDrug
0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion
| Study group | Role | What they receive |
|---|---|---|
| Group Dexmedetomidine | Experimental | Group Dexmedetomidine receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion Receives: Drug: Dexmedetomidine |
| Group Ketamine | Experimental | Group Ketamine receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shivering grade
Shivering of patients will be grouped into five grades; Grade 0: lack of shivering, Grade I: slight shivering (inconsiderable yet apparent peripheral vasoconstriction), Grade II: medium level shivering (muscular activity in one muscle group only), Grade III: severe shivering (muscular activity in more than one muscle group without generalized shivering), Grade IV: generalized shivering.
Measured: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChillsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to either group Dexmedetomidine (receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion) OR group Ketamine (receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block. In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nida Shahid, Hamdard University
- Investigators
- Nida Shahid, MBBS,FCPS, Principal investigator, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481281
- Sponsor's protocol ID
- N0331
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 Aug 2022
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05481281
- Acronym / sponsor ID
- N0331
- Conditions
- Chills
- Keywords
- spinal anesthesia, vaginal hysterectomy, shivering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 1 Aug 2022 (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.
comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.
Detailed description
In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either group Dexmedetomidine (receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion) OR group Ketamine (receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block. In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.
| Arm | Type | Receives |
|---|---|---|
| Group Dexmedetomidine | Experimental | Drug: DexmedetomidineGroup Dexmedetomidine receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion |
| Group Ketamine | Experimental | Drug: KetamineGroup Ketamine receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of age 45-55 years requiring vaginal hysterectomy
- American Society of Anesthesiology (ASA) of Grade I-II
Key exclusion criteria (5 listed)
- Patients unwilling or non-cooperative for spinal anesthesia
- Patients with uncontrolled hypertension, vascular or coronary disease,
- patients with increased intraocular or intracranial pressure
- Patients with known bleeding and psychiatric disorders
- Patients taking anti platelets drugs.
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 |
|---|---|---|
| DexmedetomidineI/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion | Drug | Group Dexmedetomidine |
| Ketamine0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion | Drug | Group Ketamine |
Primary outcome
Change in Shivering grade
Time frame: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively
Shivering of patients will be grouped into five grades; Grade 0: lack of shivering, Grade I: slight shivering (inconsiderable yet apparent peripheral vasoconstriction), Grade II: medium level shivering (muscular activity in one muscle group only), Grade III: severe shivering (muscular activity in more than one muscle group without generalized shivering), Grade IV: generalized shivering.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Nida Shahid, MBBS,FCPS principal investigator
Hamdard University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Ketamine in people with Chills, run by Hamdard University.
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 2 inclusion and 5 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nida Shahid, MBBS, FCPS (+923332358698, nida-shahid2011@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shivering grade (time frame: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively). 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 1 Aug 2022.