Dexmedetomidine Versus Nefopam for management of post spinal anesthesia shivering:A randomized double-blind controlled study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001124628
• Date of registration: 23/10/2014
• Prospective Registration: Yes
• Primary sponsor: South valley university
• Public title: Dexmedetomidine Versus Nefopam for management of post spinal anesthesia shivering:A randomized double-blind controlled study
• Scientific title: Dexmedetomidine Versus Nefopam for management of post spinal anesthesia shivering
• Date of first enrolment: 01/11/2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001124628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Egypt

Contacts

• Name: Dr Hatem saber Mohamed

• Name: Dr Hatem saber Mohamed

Key inclusion & exclusion criteria

Inclusion criteria: ASA I and II patients scheduled for elective lower abdominal,lower limb , orthopedic and plastic surgeries under spinal anesthesia
Exclusion criteria: Known hypersensitivity to dexmedetomidine or Nefopam,cardiopulmonary,renal or hepatic diseases,patients with a contra indication to spinal anesthesia e.g coagulation disorders,patients with failed or partial spinal block or those who do not agree to participate in the study

Age minimum: 18 Years
Age maximum: 60 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)

dexmedetomidine in a dose of 0.5Ug/Kg intravenous(i.v.) or Nefopam in a dose of 0.15mg/Kg I.v. In the respective groups.each drug was diluted into 5 ml by isotonic saline and given by slow I.v.( one minute) at the onset of shivering.either of the two drugs was given according to the group in the postoperative spinal anesthesia period to patients who develop grade III or IV shivering . When shivering recures additional dose of either of the two drugs according to the group can be given as the same previous dose and recorded.

Primary Outcome(s)

Time of stoppage of postspinal anesthesia shivering after treatment with either dexmedetomidine or Nefopam.[We record shivering every minute after I. V. Injection of either dexmedetomidine or Nefopam for the first five minutes of the injections and record time of its stoppage after treatment.]

Secondary Outcome(s)

Duration of effective postspinal analgesia after treatment with either dexmedetomidine or Nefopam. It is calculated from intrathecal bupivacaine injection to patient first request for rescue analgesic guided by visual analogue scale . Adverse effects are not outcome of the study.[Duration of effective postspinal analgesia from intrathecal bupivacaine administration to first rescue analgesic request.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

South valley university( SVU).

Ethics review

Status: Approved
Approval date:
Contact:

Qena faculty of medicine ethics committee