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

Adult Solid Tumor Clinical Trial

— RemivsDex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269918
• Other study ID #: 10-1056
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: June 3, 2016
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: June 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adult Intracranial Tumor
• Adult Solid Tumor
• Pain, Postoperative

Intervention

Drug:
• Remifentanil
Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
• Dexmedetomidine
DEXMEDETOMIDINE 0.4-0.7MCG/KG/HR (0.006-0.012mcg/kg/min) THROUGHOUT THE PROCEDURE BASED ON HEMODYNAMICS

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) pain relief.	every 15 minutes, during the first hour	No
Primary	Pain relief	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) pain relief	every hour	No
Primary	perioperative hemodynamics	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.	15 minutes after arrival in PACU	No
Primary	perioperative hemodynamics	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.	30 minutes after arrival in PACU	No
Primary	perioperative hemodynamics	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.	45 minutes after arrival in PACU	No
Primary	perioperative hemodynamics	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.	one hour after arrival in PACU	No
Primary	perioperative hemodynamics	The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.	90 minutes after arrival in PACU	No
Secondary	Wake Up Time comparison	To compare the wake up time between Dexmedetomidine and Remifentanil. To compare the time to neurological evaluation (orientation to person/time and place) between the two drugs	from study drug stop until subject is alert	No
Secondary	Time to discharge comparison	To Compare the time to fitness to discharge from PACU based on Aldrete's score.	discharge from PACU comparison	No
Secondary	Side effects evaluation comparison	To evaluate side effects like nausea, emesis and shivering	during time in PACU	No
Secondary	Nursing workload comparison	To evaluate the nurses workload when either of the two drugs are given in terms of a scoring sheet given to the nurses.	during PACU stay	No