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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Anesthesia; Reaction

Treatments: Procedure: Awaken test; Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium; Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium

Study type: Interventional

Funder types: Other

Identifiers

NCT02143362

Dex anesthesia

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Procedure: Awaken test

Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium

Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium

Control group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Awaken test

Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium

Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium