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

Anesthesia; Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02143362
• Other study ID #: Dex anesthesia
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 15, 2014
• Last updated: July 3, 2014
• Start date: June 2014

Study information

• Verified date: July 2014
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia; Reaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of awaken test		The whole time of surgery,about 8 hours	No
Primary	The time from starting to awaken test to patient wakes up		From starting to awaken test to patient wakes up,about 3 hours	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	The duration of anesthesia from baseline to patient wake up		From baseline to patient wake up ,about 3 hours	No
Secondary	The dosage of Cisatracurium before patient wakes up		From starting to awaken test to patient wakes up,about 3 hours	No
Secondary	The dosage of propofol before patient wakes up		From starting to awaken test to patient wakes up,about 3 hours	No
Secondary	The dosage of remifentanil before patient wakes up		From starting to awaken test to patient wakes up,about 3 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No