Shivering, Spinal AnesthesiaPhase 2/3NCT06082076
Prevention of Shivering Associated With Spinal Anesthesia
A Phase 2/3 study testing Dexmedetomidine, Ketamine and Meperidine in people with Shivering, Spinal Anesthesia, run by Assiut University.
Trial summary
The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shivering, Spinal Anesthesia
- What is being tested?
- Dexmedetomidine, Ketamine and Meperidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Dec 2024
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II
Who cannot join
- Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.
The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy
- Conditions
- Shivering, Spinal Anesthesia
- Being tested
- Dexmedetomidine, Ketamine, Meperidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia
KetamineDrug
Patient will will receive ketamine 0.5 mg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia
MeperidineDrug
If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine
| Study group | Role | What they receive |
|---|---|---|
| Group D (dexmedetomidine group) | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Group K (ketamine group) | Active comparator | Not described Receives: Drug: Ketamine |
| Group C (control group) | Placebo comparator | Not described Receives: Drug: Meperidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering
Incidence of shivering post intrathecal anesthesia is recorded
Measured: During operation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shivering, Spinal AnesthesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Galal Mohammed Mohammed, Assiut University
- Investigators
- Essam Ez Abdelhakeem, Professor, Study director, Assiut UniversitySeham Mo Moeen, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082076
- Sponsor's protocol ID
- Shivering and anesthesia
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 13 Oct 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.
- ClinicalTrials.gov ID
- NCT06082076
- Acronym / sponsor ID
- Shivering and anesthesia
- Conditions
- Shivering, Spinal Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Oct 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.
The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D (dexmedetomidine group) | Active comparator | Drug: Dexmedetomidine |
| Group K (ketamine group) | Active comparator | Drug: Ketamine |
| Group C (control group) | Placebo comparator | Drug: Meperidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II
Key exclusion criteria (1 listed)
- Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or 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 |
|---|---|---|
| DexmedetomidinePatients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia | Drug | Group D (dexmedetomidine group) |
| KetaminePatient will will receive ketamine 0.5 mg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia | Drug | Group K (ketamine group) |
| MeperidineIf the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine | Drug | Group C (control group) |
Primary outcome
Incidence of shivering
Time frame: During operation time
Incidence of shivering post intrathecal anesthesia is recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
Essam Ez Abdelhakeem, Professor study director
Assiut University
Seham Mo Moeen, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine, Ketamine and Meperidine in people with Shivering, Spinal Anesthesia, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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. 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 combined 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.
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 Ahmed Ga Mohammed, Resident (+201091339220, ahmedgalalm678@gmail.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: During operation time). 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 13 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.