Clinical trial NCT01269918: A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Official title: A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Intracranial Tumor
Adult Solid Tumor
Keywords: Craniotomy, pain relief
Adult solid neoplasm
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Detailed description: Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia. At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation. Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain. (2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.

Eligibility criteria: Inclusion Criteria:

Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:

* Age: Older than 18
* Primary and redo cases will be included
* Duration of surgery not exceeding 6 hrs.

Exclusion Criteria:

* Patient refusal
* Emergency craniotomy
* Morbid obesity
* Uncontrolled hypertension - DBP more than 110
* Cardiac conduction defects
* Patients with chronic pain.

Primary outcomes:
measure: Hemodynamics
timeFrame: 15, 30, 45, 60, and 90 minutes after extubation.
measure: Postoperative Pain
timeFrame: 15, 30, 45, 60, and 90 minutes after extubation.
measure: Total Opioid Consumption
timeFrame: Initial 90 minutes of recover after surgery
Secondary outcomes:
measure: Heart Rate
timeFrame: 15, 30, 45, 60, and 90 minutes after extubation.
measure: Modified Short Orientation Memory Concentration Test (SOMCT)
timeFrame: 15, 30, 45, 60, and 90 minutes after extubation.
measure: Aldrete Score
timeFrame: 15, 30, 45, 60, and 90 minutes after extubation.
measure: Nursing Workload Comparison
timeFrame: 90 minutes after extubation
measure: Drug Stop Time to Open Eyes
timeFrame: Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
measure: Drug Stop Time to Recall
timeFrame: Time between extubation until patients could say their names.
measure: Drug Stop Time to Fitness to Discharge
timeFrame: Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
measure: End Case to Post Anesthesia Care Unit (PACU) Discharge
timeFrame: End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
measure: Postoperative Nausea
timeFrame: Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
measure: Postoperative Vomitting
timeFrame: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
measure: Postoperative Shivering
timeFrame: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Shobana Rajan, MD
role: PRINCIPAL_INVESTIGATOR
References: