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Completed

NCT Number: NCT02382432

Dexmedetomidine in Post Spinal Anesthesia Shivering

This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university hospital, Assiut, Egypt

Asyut, Assiut Governorate, 715715, Egypt

About this study

Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.

Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period

Exclusion criteria

  • Patients with BMI>30 kg /m2
  • Initial body temperature >38 C or <36 C and those with a history of convulsions
  • Multiple allergies
  • Thyroid disease
  • Parkinson's disease
  • Dysautonomia
  • Raynaud's syndrome
  • Hypertension
  • Coronary artery disease or other cardio-respiratory or neuromuscular pathology
  • Middle ear pathology
  • A known history of alcohol use
  • Treatment with sedative hypnotic agents or vasodilators
  • Having contraindications to spinal anesthesia

Treatment and study plan

Pethidine 0.4mg/kg

Drug

2ml intravenous bolus slowly injected in 2minutes.

Other names: Meperidine

Dexmedetomidine

Drug

2ml intravenous bolus slowly injected in 2minutes

Other names: Precedex

Primary outcomes

  1. Shivering response rate (%)

    Time frame: 10 minutes

    complete cessation of shivering activity within 10 minutes after study drug injection

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 6 hours after study drug injection

    find for systolic hypotension, hypertension

  2. sedation

    Time frame: 6 hours after study drug injection

    using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking).

  3. peripheral arterial saturation

    Time frame: 6 hours after study drug injection

    find for hypoxia

  4. diastolic blood pressure

    Time frame: 6 hours after study drug injection

    find for diastolic hypertension or hypotension

  5. Postoperative adverse events

    Time frame: 24 hours postoperative

    postoperative nausea and vomiting, urine retention, post dural puncture headache ect.

Other outcomes

  1. heart rate

    Time frame: 6 hours after study drug injection

    find for bradycardia or tachycardia

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2015
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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