Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial

Background: Favorable quality of recovery
from general anesthesia in neurosurgical patients is an important goal for
anesthesiologists. Dexmedetomidine is an emerging anesthetic adjuvant
characterized by a stable hemodynamic recovery period, and neither its sedative
nor analgesic effects influence evaluation of neurological function. We
hypothesize that a bolus injection of low-dose dexmedetomidine during general
anesthesia within minutes before the end of surgery in patients undergoing
craniotomy can improve the quality of recovery from general anesthesia, thereby
benefitting the evaluation of early-stage neurological function after surgery.

Methods/Design: Patients with
supratentorial tumors who have undergone craniotomy under general anesthesia at
the Department of Neurosurgery, First Affiliated Hospital of China Medical
University are included in this randomized controlled trial. A sample size of 150
patients is needed. Patients in the experimental group are randomly assigned to
receive intravenous bolus injection of low- and medium-dose dexmedetomidine
(0.4 and 0.8 μg/kg, respectively). Patients in the control group receive equal
doses of physiological saline. The primary outcome of the study is the quality
of recovery from general anesthesia, including awakening time, degree of sedation,
spontaneous breathing recovery time, and coughing and bucking at the time of
tracheal extubation. Secondary outcomes include postoperative analgesic
effects, hemodynamic indices, anesthesia time, operation time, and neurological
function assessment.

Discussion: The results from this trial
will provide optimal evidence for intravenous bolus injections of dexmedetomidine
at a dose that can improve the quality of recovery from general anesthesia
after craniotomy for supratentorial tumors.

Trial registration: ClinicalTrails.gov
identifier: NCT02007798; registered on 6 December 2013.