Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up

Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial

The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Reaction
• Intervention / Treatment: Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Procedure: Awaken test

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Ongoing brain functional area surgery with intraoperative wake up.
• American Society of Anesthesiologists class I to II.
• Aged between 18 and 65 years old.
• Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion Criteria:

• History of hypertension.
• Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
• Mental disability or mental disease.
• Use of sedative drug.
• Suspected or confirmed long term use of narcotic analgesics.
• Inability to exchange.
• Suspected or confirmed difficult airway.
• Suspected of malignant hyperthermia.
• Neuromuscular disease.
• Allergic to investigational products or with other contraindication.
• Subjects who are breastfeeding or pregnant.
• Participated in other study within 30 days .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.; Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.; The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.	Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium; Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.; Intermittent injection cisatracurium (0.15mg/kg).; A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.; Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.; Intermittent injection cisatracurium (0.05mg/kg).; Procedure: Awaken test; Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.; In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .; Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.; Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .; Patients will receive initial anesthesia after finish awaken test.
Placebo Comparator: Control group; Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.; Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.; The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.	Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium; Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.; Intermittent injection cisatracurium (0.15mg/kg).; A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.; Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.; Intermittent injection cisatracurium (0.05mg/kg).; Procedure: Awaken test; Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.; In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .; Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.; Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .; Patients will receive initial anesthesia after finish awaken test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of awaken test	The whole time of surgery,about 8 hours
The time from starting to awaken test to patient wakes up	From starting to awaken test to patient wakes up,about 3 hours
Blood sugar concentration	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Cortisol concentration	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Epinephrine concentration	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Norepinephrine concentration	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test

Secondary Outcome Measures

Outcome Measure	Time Frame
The duration of anesthesia from baseline to patient wake up	From baseline to patient wake up ,about 3 hours
The dosage of Cisatracurium before patient wakes up	From starting to awaken test to patient wakes up,about 3 hours
The dosage of propofol before patient wakes up	From starting to awaken test to patient wakes up,about 3 hours
The dosage of remifentanil before patient wakes up	From starting to awaken test to patient wakes up,about 3 hours
Heart rate	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Mean arterial pressure	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Bispectral electroencephalogram index	30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Propofol; Dexmedetomidine; Intraoperative wake up; Closed loop of target controlled infusion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Anesthetics; Remifentanil; Propofol; Cisatracurium; Atracurium
• Other Study ID Numbers: Dex anesthesia