Efficacy of Intrathecal Versus Intravenous Dexmedetomidine for Prevention of Post Spinal Anesthesia Shivering

Postoperative Shivering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02965586
• Other study ID #: 360
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 9, 2016
• Last updated: January 10, 2018
• Start date: November 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Shivering

Intervention

Drug:
• intrathecal
intrathecal block will be performed in sitting position using 25 G spinal needle at either the L3-L4 or L4-L5 intervertebral spaces.

Locations

Country	Name	City	State
Egypt	Assuit University	Assuit	Iorg0006563

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative shivering	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.	0, 10,20,30,40, 50,60 min
Secondary	sedation score	a 5- point scale: 1 = fully awake and oriented, 2 = drowsy, 3 = eyes closed but open on command, 4 = eyes closed but open to mild physical stimulation, and 5 = eyes closed and unresponsive to mild physical stimulation	0, 10,20, 30, 40, 50, 60 min
Secondary	side effect	hypotension, bradycardia, itching, nausea, vomiting	0, 10,20, 30, 40, 50, 60 min