Clinical Trial: Mild Hypothermia During Intracranial Aneurysm Clipping

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms

Brief Summary: The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.

Detailed Summary:

Methods: All the patients meeting the study criteria will be randomized into two groups. Normothermia (NT) group : during the whole period of surgery the body temperature will be maintained in the range 35.8° C - 36.8° C. Hypothermia (HT) group: After induction to general anaesthesia the patients will be cooled to body temperature 33.8° C - 34.8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping. Warming up of the patients will start immediately afterwards. The target temperature at the time of extubation will be over 36° C in both groups (one of the extubation criteria).

Specific management: No pharmacological sedation (premedication) will be given to the patients. Cooling/warming mattress/blanket (PlastiPad® Blanketrol® III Cincinnati Sub-Zero, USA) will be placed on the operating table. Induction to general anesthesia will be with propofol 2 mg/kg/b.w i.v. (with possible adjustment according to age and/or physical status of the patient) and atracurium 0,5 mg/kg/b.w. i.v. After orotracheal intubation, the esophageal temperature probe will be inserted (depth of insertion 25 cm from the nostril). Afterwards, the envelope with randomization will be opened by the anaesthesiologist.

In HT group, the targeted body temperature will be set to 33° C and a bolus of saline 250 ml cooled to 5° C will be administered.

In NT group, the targeted body temperature will be set to 36° C and a bolus of saline 250 ml warmed to 37° C using infusion heater will be administered.

Standard preparation for the surgery will continue afterwards (insertion of central venous catheter, arterial catheter, urinary catheter). After finishing the prepar
Sponsor: University Hospital Hradec Kralove

Current Primary Outcome: Changes in Sidestream Dark Field (SDF) imaging variables [ Time Frame: 1 and 2 hours after skin incision ]

brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in diameter of small brain arteries at operating site [ Time Frame: 1 and 2 hours after skin incision ]
    will be measured by SDF probe
  • Occurrence of vasospasms [ Time Frame: within the first 14 days after surgery ]
    measured by transcranial Doppler


Original Secondary Outcome: Same as current

Information By: University Hospital Hradec Kralove

Dates:
Date Received: August 27, 2015
Date Started: December 2015
Date Completion: September 2018
Last Updated: October 17, 2016
Last Verified: October 2016