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NCT Number: NCT01269918

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

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.

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Key information

Conditions

Adult Intracranial Tumor Adult Solid Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remifentanil

Drug

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

Other names: Ultiva, G187084B

Dexmedetomidine

Drug

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.

Other names: Precedex, Dexmedetomidine Hydrochloride

Primary outcomes

  1. Hemodynamics

    Time frame: 15, 30, 45, 60, and 90 minutes after extubation.

    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.

  2. Postoperative Pain

    Time frame: 15, 30, 45, 60, and 90 minutes after extubation.

    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.

  3. Total Opioid Consumption

    Time frame: Initial 90 minutes of recover after surgery

    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.

Secondary outcomes

  1. Heart Rate

    Time frame: 15, 30, 45, 60, and 90 minutes after extubation.

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

  2. Modified Short Orientation Memory Concentration Test (SOMCT)

    Time frame: 15, 30, 45, 60, and 90 minutes after extubation.

    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.

  3. Aldrete Score

    Time frame: 15, 30, 45, 60, and 90 minutes after extubation.

    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.

  4. Nursing Workload Comparison

    Time frame: 90 minutes after extubation

    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).

  5. Drug Stop Time to Open Eyes

    Time frame: Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.

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

  6. Drug Stop Time to Recall

    Time frame: Time between extubation until patients could say their names.

    Time between extubation until patients could say their names.

  7. Drug Stop Time to Fitness to Discharge

    Time frame: Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.

  8. End Case to Post Anesthesia Care Unit (PACU) Discharge

    Time frame: End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.

    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.

  9. Postoperative Nausea

    Time frame: Whether patients had nausea or not, from anesthesia stop time until hospital discharge.

    Indicator of whether patients had nausea or not

  10. Postoperative Vomitting

    Time frame: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.

    Indicator of whether patients had postoperative vomiting.

  11. Postoperative Shivering

    Time frame: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.

    Indicator of whether patients had postoperative shivering.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: RemivsDex

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2011
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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