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

NCT ID: NCT02143362

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

Brief Summary

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.

Conditions

Anesthesia; Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine group

1. Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.

2. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.

3. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.

Group Type: EXPERIMENTAL

Anesthesia induction,propofol, remifentanil ,cisatracurium

Intervention Type: DRUG

1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.

2. Intermittent injection cisatracurium (0.15mg/kg).

3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.

Anesthesia maintenance , propofol,remifentanil,cisatracurium

Intervention Type: DRUG

1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.

2. 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.

3. Intermittent injection cisatracurium (0.05mg/kg).

Awaken test

Intervention Type: PROCEDURE

1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.

2. 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 .

3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.

4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .

5. Patients will receive initial anesthesia after finish awaken test.

Control group

1. Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.

2. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.

3. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.

Group Type: PLACEBO_COMPARATOR

Anesthesia induction,propofol, remifentanil ,cisatracurium

Intervention Type: DRUG

1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.

2. Intermittent injection cisatracurium (0.15mg/kg).

3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.

Anesthesia maintenance , propofol,remifentanil,cisatracurium

Intervention Type: DRUG

1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.

2. 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.

3. Intermittent injection cisatracurium (0.05mg/kg).

Awaken test

Intervention Type: PROCEDURE

1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.

2. 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 .

3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.

4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .

5. Patients will receive initial anesthesia after finish awaken test.

Interventions

Anesthesia induction,propofol, remifentanil ,cisatracurium

1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.

2. Intermittent injection cisatracurium (0.15mg/kg).

3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.

Intervention Type: DRUG

Anesthesia maintenance , propofol,remifentanil,cisatracurium

1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.

2. 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.

3. Intermittent injection cisatracurium (0.05mg/kg).

Intervention Type: DRUG

Awaken test

1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.

2. 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 .

3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.

4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .

5. Patients will receive initial anesthesia after finish awaken test.

Intervention Type: PROCEDURE

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Dex anesthesia

Identifier Type: -

Identifier Source: org_study_id