Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Dexmedetomidine

Remifentanil

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Analgesics, Opioid

Narcotics

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Shobana Rajan, MD

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.

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.

A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.

Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.

Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.

Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.

The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores \> 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.

The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.

To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).

time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery

Time between extubation until patients could say their names.

Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.

Indicator of whether patients had nausea or not

Indicator of whether patients had postoperative vomiting.

Indicator of whether patients had postoperative shivering.

The Cleveland Clinic

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Total

Age, Continuous

Gender

Daniel Sessler, MD

Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.

Hemodynamics

Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.

Postoperative Pain

Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test

Total Opioid Consumption

Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.

Heart rate 15 minutes after extubation

Heart rate 30 minutes after extubation

Heart rate 45 minutes after extubation

Heart rate 60 minutes after extubation

Heart rate 90 minutes after extubation

Heart Rate

Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.

SOMCT 15 minutes after extubation

SOMCT 30 minutes after extubation

SOMCT 45 minutes after extubation

SOMCT 60 minutes after extubation

SOMCT 90 minutes after extubation

Modified Short Orientation Memory Concentration Test (SOMCT)

Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.

Aldrete score at 15 minutes after extubation

Aldrete score at 30 minutes after extubation

Aldrete score at 45 minutes after extubation

Aldrete score at 60 minutes after extubation

Aldrete score at 90 minutes after extubation

Aldrete Score

Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.

Nursing Workload Comparison

Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.

Drug Stop Time to Open Eyes

Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.

Drug Stop Time to Recall

Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.

Drug Stop Time to Fitness to Discharge

Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression

End Case to Post Anesthesia Care Unit (PACU) Discharge

Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.

Postoperative Nausea

Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.

Postoperative Vomitting

Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain	NCT01269918	Adult Intracran... Adult Solid Tum...	Remifentanil Dexmedetomidine	18 Years - 80 Years	The Cleveland Clinic
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain	NCT01269918	Adult Intracran... Adult Solid Tum...	Remifentanil Dexmedetomidine	18 Years - 80 Years	The Cleveland Clinic

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