Intravenous low dose Ketamine injection versus Dexmedetomidine infusion for prevention of intraoperative shivering during spinal anesthesia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001246673
• Date of registration: 27/11/2014
• Prospective Registration: No
• Primary sponsor: Ain Shams university
• Public title: Intravenous low dose Ketamine injection versus Dexmedetomidine infusion for prevention of intraoperative shivering during spinal anesthesia
• Scientific title: Sixty patients of both sexes between 20 to 50 years old undergoing elective lower abdominal surgery and elective orthopedic lower limb surgery under spinal anesthesia receiving low dose ketamine injection versus dexmedetomidine infusion to control post-spinal shivering in a clinical trial study with dexmedetomidine advantage.
• Date of first enrolment: 15/01/2013
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001246673.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Dr Mostafa Mansour Houssein

• Name: Dr Mostafa Mansour Houssein

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing elective lower abdominal surgery and elective orthopedic lower limb surgery were included in the study. Patients selected were American Society of Anesthesiologists (ASA) I and II physical status.
Exclusion criteria: Patients with thyroid disease, Parkinson's disease, dysautonomia, Raynaud's syndrome, cardiopulmonary disease, a history of allergy to the agents to be used, a need for blood transfusion during surgery, an initial core temperature > 37.5 degree C or < 36.5 degree C, a known history of alcohol use, use of sedative-hypnotic agents, use of vasodilators, or having contraindications to spinal anesthesia were excluded from the study.

Age minimum: 20 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Anaesthetics

post-spinal anesthesia shivering;
post-spinal anesthesia shivering

Intervention(s)

Patients included in group D received Dexmedetomidine infusion (loading dose of 1mcg/kg over 10 minutes followed by a maintenance dose of 0.4mcg/kg/h) started immediately after giving spinal anesthesia for elective lower abdominal surgeries and elective lower limb orthopedic surgeries to control post-spinal anesthesia shivering and maintained until completion of surgery.

Primary Outcome(s)

measurement of post-spinal anesthesia shivering using 5 points rating scale, with grade 0 indicating no shivering to grade 4 indicating gross muscle activity involving the whole body.[shivering score is measured 10 minutes after spinal anesthesia then every 10 minutes till end of operation.]

Secondary Outcome(s)

Sedation score [sedation score is assessed every 10 minutes after onset of ketamine injection or dexmedetomidine infusion till the end of operation.]

measurement of hemodynamic parameters (heart rate from ECG monitor, temperature by axillary thermometer, mean arterial pressure by automated non-invasive blood pressure monitoring, SPO2 by pulse oximetry)[hemodynamic parameters are measured as a baseline before start of spinal anesthesia then every 10 minutes after spinal anesthesia till end of operation.]

Secondary ID(s)

none

Source(s) of Monetary Support

Ain Shams university

Ethics review

Status: Approved
Approval date:
Contact:

local ethical committee of faculty of medicine, ain shams universty.