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

Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Adult Intracranial Tumor, Adult Solid Tumor

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain Relief

Outcome Description:

The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) pain relief.

Outcome Time Frame:

every 15 minutes, during the first hour

Safety Issue:


Principal Investigator

Shobana Rajan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

March 2013

Related Keywords:

  • Adult Intracranial Tumor
  • Adult Solid Tumor
  • Craniotomy, pain relief
  • Adult solid neoplasm
  • Pain, Postoperative
  • Brain Neoplasms



Cleveland Clinic Foundation Cleveland, Ohio  44195
The Cleveland Clinic Foundation Cleveland, Ohio