- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544256
Mild Hypothermia During Intracranial Aneurysm Clipping
Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 preparation (coming of the surgeon), the infusion of mannitol 15% at the dose 0,5 g/kg i.v. is started and set for the duration of 40 minutes. Monitoring: basic monitoring (SpO2, ECG, end-tidal carbon dioxide (EtCO2), NIBP) together with extended monitoring (invasive blood pressure, response entropy/state entropy (RE/SE), neuromuscular transmission module (NMT), surgical plethysmography index (SPI).
Anesthesia management: Desflurane anesthesia in O2/air mixture with concentration of oxygen (FiO2) 0.45 will be used with targeted concentrations of desflurane according to the age groups initially (to achieve end-tidal concentration of desflurane 6 V%, 5.5 V%, 5 V%, 4.5 V%, and 4 V% in age groups 18 - 30, 30 - 40, 40 - 55, 55 - 65, and over 65 years respectively), further adjustment will be done to keep target RE/SE 40-50 in the individual patient. Analgesia will be provided by bolus i.v. administration of remifentanil 80 ug before induction, followed by continuous administration 0.25 ug/kg/min initially with further stepwise adjustment according to SPI (3-5 ml/hour steps). Target analgesia according to SPI is defined as the initial figure of SPI recorded 5 minutes after induction plus 10 points. Figures of SPI exceeding for 1 minute the target figure indicate the need of increasing the rate of remifentanil infusion. Atracurium boluses will be used for muscle relaxation, NMT monitoring by train of four (TOF) will be done in 5 minute intervals, TOF count over 1 indicating need of further atracurium bolus. Starting from dura mater suture, no further boluses of atracurium will be given.
Hemodynamic stability: Systolic and mean arterial pressures are maintained in the range of ± 15% of usually measured BP for individual patient. Decrease of BP bellow this figure in the duration of at least 5 minutes is indication for continuous administration of noradrenaline. Nimodipine is administered continuously during the whole procedure, infusion rate is set at the ICU, no adjustments are indicated at the OR. Volume therapy is provided by continuous balanced isotonic crystalloid infusion 5 ml/kg/h.
Microcirculation measurement: After craniotomy, microcirculation will be measured by SDF probe at the labelled sites of the brain (edge of craniotomy and at the distance of 2 cm from aneurysm). After aneurysm clipping, the measurement will be repeated at the same sites.
Finishing anaesthesia: At the beginning of skin suture, the remifentanil infusion is stopped. After finishing the skin suture, the administration of desflurane is stopped and end-tidal control flush out of desflurane is activated.
Extubation criteria: consciousness Glasgow coma scale (E-2-3/V-1-3/M-6), normotension including noradrenaline administration in stable continuous dose, normocapnia, spontaneous ventilation with respiratory rate (RR) over 10/minute, tidal volume (TV) 4-6 ml/kg, preserved coughing reflex, SpO2 over 95% without/with O2 administration, normothermia over 36° C, train of four ratio over 92%.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hradec Kralove, Czech Republic, 50005
- University hospital Hradec Králové
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute subarachnoidal hemorrhage based on ruptured aneurysm
- Hunt and Hess scale 1-4
- Clipping up to 72 hours after the rupture
Exclusion Criteria:
- Known cryoglobulinemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mild hypothermia
After induction to general anaesthesia the patients will be cooled to 33° C. Targeted body temperature 33,8° C - 34,8° will be maintained up to the end of microcirculation measurement after aneurysm clipping.
|
Mild hypothermia during surgical clipping of brain aneurysm will be reached by cooling to body temperature 33,8° C - 34,8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping.
|
No Intervention: Normothermia
The body temperature will be maintained in the range 35,8° C - 36,8° C.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 and 2 hours after skin incision
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 and 2 hours after skin incision
|
Occurrence of vasospasms
Time Frame: within the first 14 days after surgery
|
measured by transcranial Doppler
|
within the first 14 days after surgery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Days of hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
Glasgow outcome score (GOS) on discharge
Time Frame: 2 weeks after operation
|
2 weeks after operation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Body Temperature Changes
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Aneurysm
- Subarachnoid Hemorrhage
- Hypothermia
- Intracranial Aneurysm
Other Study ID Numbers
- 201507-S16P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subarachnoid Hemorrhage, Aneurysmal
-
Medical University InnsbruckRecruitingSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralAustria
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingSubarachnoid Hemorrhage, Aneurysmal | Subarachnoid Hemorrhage, SpontaneousItaly
-
El Instituto Nacional de Neurologia y Neurocirugia...CompletedBrain Ischemia | Subarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Delayed Cerebral Ischemia | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralMexico
-
IRCCS San RaffaeleFondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera... and other collaboratorsRecruitingSubarachnoid Hemorrhage, Aneurysmal | Poor Grade Subarachnoid HemorrhageItaly
-
Hackensack Meridian HealthRecruitingStroke | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Cerebral Aneurysm | Cerebral Ischemia | Vasospasm, CerebralUnited States
-
University of Texas Southwestern Medical CenterRecruitingSubarachnoid Hemorrhage, AneurysmalUnited States
-
Milton S. Hershey Medical CenterRecruiting
-
Second Affiliated Hospital, School of Medicine,...RecruitingSubarachnoid Hemorrhage, AneurysmalChina
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingAneurysmal Subarachnoid HemorrhageChina
-
Ascension South East MichiganRecruitingAneurysmal Subarachnoid HemorrhageUnited States
Clinical Trials on Mild hypothermia
-
RenJi HospitalXiangya Hospital of Central South University; West China Hospital; Qilu Hospital... and other collaboratorsCompletedBrain Injuries | Craniocerebral TraumaChina
-
WellStar Health SystemWithdrawnIschemic Stroke | HypothermiaUnited States
-
University of LeipzigCompletedCardiogenic Shock | Acute; Myocardial Infarction, ComplicationsGermany
-
University of MiamiTerminatedHypothermiaUnited States
-
Medivance, Inc.Completed
-
University Hospital Schleswig-HolsteinUniversity of Leipzig; University of Jena; University of Hamburg-EppendorfTerminated
-
University of AarhusCompletedCardiac Arrest | HypothermiaDenmark, Norway
-
University Hospital, BrestCompleted
-
Danish Procalcitonin Study GroupLundbeck Foundation; TRYG FoundationTerminatedSeptic ShockNetherlands, Denmark, United States
-
Imperial College LondonMedical Research CouncilCompletedHypoxia | Seizures | Asphyxia Neonatorum | EncephalopathyUnited Kingdom