The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine

The current study is designed to investigate the difference of plasma orexin A levels between Dexmedetomidine group and controlled group at emergence time from total intravenous anesthesia who will undergo elective lumbar surgery.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Saline

Detailed Description

DESIGNING: Fifty-one patients with ASA physical status I or II scheduled for elective surgery under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was maintained with target controlled infusion propofol (targeted concentration:2-5ug/ml ) and remifentanil (targeted concentration: 2-6ng/ml ). Muscle relaxation was maintained with intermittent, but it do not injected in 1h before surgery completion. Propofol and remifentanil were titrated to maintain the bispectral index (BIS) between 40 and 60 during anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by controlled mechanical ventilation. When the surgery was completed the investigators adjust the targeted concentration of propofol 2ug/ml and targeted concentration of remifentanil to 2ng/ml then stop all anesthetics. Dexmedetomidine group target controlled infusion dexmedetomidine (induction dose 1ug/kg with 10min, maintain dose 0.4ug/kg/h until 30min before surgery completion). Control group infusion same saline. Record time from stopping anesthetics to emergence and total doses of anesthetics. Arterial blood (2.5ml) was collected at the following time, such as before and 1h after induction of anesthesia, at emergence (1 min after tracheal extubation) and half an hour after tracheal extubation. 2.0ml Arterial blood was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored at -80 ◦C until assay for orexin A concentrations. 0.5ml Arterial blood was measured blood glucose.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Anesthesiology department of General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant is Adult (≥18 years old and ≤60 years old)
2. Participants with a Body Mass Index (BMI) 20-25 kg/m2
3. Participants with ASA physical status Ⅰor Ⅱ
4. Participants with Heart function rating Ⅰor Ⅱ
5. Patients will undergo elective surgery and general anesthesia
6. The operation time is 2h to 4h.

Exclusion Criteria:

1. Participant is a pregnant woman or a nursing mother.
2. Participants have a history of narcotics allergic reactions.
3. Indices of liver or kidney function is twice higher than normal.
4. Participants have a history or diagnosis of depression.
5. Participants have a history of Brain Trauma.
6. Participants have a history of narcotics addiction or drug addiction.
7. Participants or his family have an International Classification of Sleep
8. Disorders diagnosis of obstructive sleep apnea syndrome.
9. Patients are refuse this trail or are not able to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Induction dose of dexmedetomidine is 1ug/kg with 10min, maintain dose is 0.4ug/kg/h until 30 min before surgery completion.	Drug: Dexmedetomidine; Dexmedetomidine is common used to improve the prognosis and life quality of patients.; Other Names: Dexmedetomidine is a highly selective α2-adrenoceptor agonist.
Placebo Comparator: Saline group; Control group given equal volume of saline with the dexmedetomidine group.	Drug: Saline; It is safe Placebo.; Other Names: It is safe Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
orexin A concentrations	2 year

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Study Chair: Zhihua Wang, M.D., General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: XZ2015020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No