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Clinical Trials/NCT02965586
NCT02965586
Unknown
Phase 1

Efficacy of Intrathecal Versus Intravenous Dexmedetomidine for Prevention of Post Spinal Anesthesia Shivering in Patients Undergoing TURP

Assiut University1 site in 1 country90 target enrollmentNovember 2016

Overview

Phase
Phase 1
Intervention
intrathecal
Conditions
Postoperative Shivering
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
Change in postoperative shivering
Last Updated
8 years ago

Overview

Brief Summary

compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.

Detailed Description

Shivering is a frequent complication following SA. It is distressing and unpleasant experience for patients. The incidence of shivering has been reported to be about 36-85% after SA. It is more common in TURP that may be due to absorption of large amount of irrigating fluid at room temperature. Shivering may occur as a response to hypothermia. However, it may also occur in normothermic patients. SA impairs the thermoregulation system by inhibiting tonic vasoconstriction below the level of anesthesia through sympathetic and somatic neural blockade. With internal redistribution of heat from the core to the peripheral compartment, the loss of thermoregulatory vasoconstriction results in increased heat loss from body surfaces in excess of metabolic heat production. Excessive shivering can result in an increased oxygen demand up to 400% of normal and induce metabolic derangements such as hypoxemia, lactic acidosis and hypercarbia. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. Considering these undesirable consequences of shivering, measures to prevent in the postoperative period are important. Various drugs have been investigated for the prevention or treatment of postoperative shivering, including meperidine, ketamine, tramadol, doxapram and dexmedetomidine. Dexmedetomidine is an α 2-agonist that decreases vasoconstriction and shivering thresholds and when administered with meperidine additively reduces the shivering threshold in healthy volunteers. Intraoperative dexmedetomidine reduces postanesthetic shivering as does meperidine after surgery. One bolus dose of dexmedetomidine 1 μg/kg with or without continuous infusion was used in the previous antishivering studies. Dexmedetomidine also has sedative and analgesic effects in the postoperative period. Patients who received an intraoperative injection of dexmedetomidine were more sedated after surgery than those who received placebo. This can be a disadvantage particularly for patients undergoing outpatient surgery. Addition of intrathecal dexmedetomidine to heavy bupivacaine 0.5% was more advantageous than fentanyl with special regard to its analgesic properties in diabetic surgical patients. Few studies have been done to evaluate the efficacy of intrathecal dexmedetomidine in attenuation and prevention of shivering in TURP. We aimed to compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
September 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain managment

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients scheduled to undergo elective trans-urethral resection of the prostate(TURP) under spinal anesthesia.

Exclusion Criteria

  • Obese patients (BMI \> 27)
  • those with hypo- or hyperthyroidism,
  • cardiopulmonary disease,
  • psychological disorders,
  • blood transfusion during surgery,
  • Parkinsonians disease, and
  • an initial body temperature above 38.0˚C or below 36.0 ˚C

Arms & Interventions

intravenous dexmedetomidine group

intrathecal 2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and will receive intravenous dexmedetomidine infusion as prepared. Dexmedetomidine will be diluted to a volume of 50 ml (4 mg ml-1) and presented as coded syringes by an anesthesiologist. I.V. bolus of dexmedetomidine 1 ug kg-1 administered by a syringe pump over a 10-min period followed by an infusion of 0.4 ug kg-1h-1 dexmedetomidine during the surgery. Just after intrathecal injection, all drugs were infused intravenously. The infusions will be stopped at the end of surgery.

Intervention: intrathecal

intrathecal dexmedetomidine group

intrathecal2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and dexmedetomidine (10µg) and will receive an equal volume of saline intravenously

Intervention: intrathecal

control group

intrathecal 2.5 ml of heavy bupivicaine0.5% pulse 0.5 mg morphine and will receive an equal volume of saline intravenously

Intervention: intrathecal

Outcomes

Primary Outcomes

Change in postoperative shivering

Time Frame: 0, 10,20,30,40, 50,60 min

Shivering will be assessed by Crossley and Mahajan scale where 0= No shivering, 1= Cyanosis and piloerection, 2 = Visible tremors only in one muscle group, 3 = Visible tremors in more than one muscle group, and 4 = intense shivering, tremors of the head, arm.

Secondary Outcomes

  • side effect(0, 10,20, 30, 40, 50, 60 min)
  • sedation score(0, 10,20, 30, 40, 50, 60 min)

Study Sites (1)

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