40 Participants Needed

Dexmedetomidine for Surgical Shivering

HP
Overseen ByHans P Sviggum, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken sedative medications like fentanyl, midazolam, ketamine, or nitrous oxide before randomization.

What data supports the effectiveness of the drug Dexmedetomidine for surgical shivering?

Research shows that Dexmedetomidine, a drug that helps calm the body, is effective in reducing shivering after surgery. Studies have found it lowers the chance of shivering in both adults and children after anesthesia.12345

Is dexmedetomidine safe for humans?

Dexmedetomidine, also known as Precedex, has been used safely in humans for various conditions, including reducing shivering after surgery. It is generally well-tolerated, but researchers are still studying the best dose to minimize side effects like changes in blood pressure.23467

How does the drug dexmedetomidine differ from other treatments for surgical shivering?

Dexmedetomidine is unique because it is an alpha-2 adrenergic agonist (a type of drug that affects certain receptors in the brain) that not only helps reduce shivering but also acts as a sedative, which can be beneficial during surgery. Unlike other treatments, it lowers the shivering threshold, making it effective in preventing and treating shivering after anesthesia.24589

Research Team

HS

Hans Sviggum, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for women having a planned cesarean delivery under spinal anesthesia, with an ASA status of 2 or 3 and no major health issues. They must be in their third trimester without signs of infection or preterm rupture of membranes (PPROM), able to consent, and not have taken certain sedatives or have allergies to dexmedetomidine.

Inclusion Criteria

I will undergo a procedure with spinal anesthesia.
I am having a cesarean delivery and will receive spinal anesthesia.
I am in my third trimester of a single pregnancy.
See 2 more

Exclusion Criteria

I have had premature rupture of membranes or signs of infection in the womb.
Oral temperature < 36Β° Celsius prior to procedure.
I am unable to give consent on my own.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Pre-operative
1 visit (in-person)

Treatment

Participants receive dexmedetomidine to treat shivering during cesarean delivery

Intraoperative
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediate post-operative

Treatment Details

Interventions

  • Dexmedetomidine
Trial OverviewThe study aims to find the best dose of Dexmedetomidine that stops shivering in 90% of patients during elective cesarean deliveries. It's focused on those who experience shivering as a side effect from the operation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: DexmedetomidineExperimental Treatment1 Intervention
IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Precedex for:
  • Sedation in intensive care settings
  • Procedural sedation
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Approved in United States as Precedex for:
  • Sedation in intensive care settings
  • Procedural sedation
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Approved in Canada as Precedex for:
  • Sedation in intensive care settings
  • Procedural sedation
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Approved in Japan as Precedex for:
  • Sedation in intensive care settings
  • Procedural sedation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

In a study of 90 female patients undergoing elective abdominal surgery, intraoperative dexmedetomidine infusion significantly reduced the incidence of post-anaesthetic shivering, with only 7 patients experiencing shivering compared to 21 in the saline group (P = 0.001).
Patients receiving dexmedetomidine also had higher sedation scores and lower pain scores in the immediate postoperative period, suggesting that it not only helps prevent shivering but may also enhance overall comfort during recovery.
Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy.Elvan, EG., OΓ§, B., Uzun, S., et al.[2022]
Dexmedetomidine significantly reduces postoperative shivering compared to placebo, with a risk ratio of 0.26 based on a meta-analysis of 39 trials involving 2,478 patients.
While dexmedetomidine is effective against shivering, its efficacy is comparable to other common anti-shivering medications, and it may cause side effects like sedation and hypotension, making it less suitable as a sole treatment for this issue.
Efficacy of dexmedetomidine on postoperative shivering: a meta-analysis of clinical trials.Liu, ZX., Xu, FY., Liang, X., et al.[2022]
In a study of 80 women undergoing laparoscopic gynecological surgery, dexmedetomidine significantly reduced the incidence of postoperative shivering (12.5% in the dexmedetomidine group vs. 37.5% in the control group).
While dexmedetomidine increased sedation and caused more dry mouth, it also resulted in lower rates of nausea and vomiting compared to the control group, indicating a favorable safety profile for its use in this context.
[Effect of dexmedetomidine in preventing shivering after general anesthesia for laparoscopic surgery: a randomized, single-blinded, and placebo-controlled trial].Wu, Y., Huang, H., Zeng, J., et al.[2022]

References

Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. [2022]
Efficacy of dexmedetomidine on postoperative shivering: a meta-analysis of clinical trials. [2022]
[Effect of dexmedetomidine in preventing shivering after general anesthesia for laparoscopic surgery: a randomized, single-blinded, and placebo-controlled trial]. [2022]
Dexmedetomidine for the treatment of postanesthesia shivering in children. [2022]
Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomized prospective study. [2022]
Effects of Dexmedetomidine On the Postoperative Shivering, Nausea, and Vomiting Among Opium User Patients Undergoing Elective Supratentorial Brain Tumor Surgery: A Randomized, Placebo, Controlled Clinical trials. [2022]
Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. [2019]
Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. [2022]
[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering]. [2022]