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

NCT02965586 | Unknown Phase 1

• 1 other identifier: 360
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Shivering

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• sedation score

  0, 10,20, 30, 40, 50, 60 min

• side effect

  0, 10,20, 30, 40, 50, 60 min

Study Arms (3)

intravenous dexmedetomidine group

ACTIVE COMPARATOR

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.

Drug: intrathecal

intrathecal dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: intrathecal

control group

PLACEBO COMPARATOR

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

Drug: intrathecal

Interventions

intrathecal DRUG

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

control group; intrathecal dexmedetomidine group; intravenous dexmedetomidine group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, Iorg0006563, 171516, Egypt

Location

MeSH Terms

Interventions

Injections, Spinal

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU and pain managment

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)