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

NCT03025295 | Completed

• 1 other identifier: XZ2015020
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• orexin A concentrations

  2 year

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Induction dose of dexmedetomidine is 1ug/kg with 10min, maintain dose is 0.4ug/kg/h until 30 min before surgery completion.

Drug: Dexmedetomidine

Saline group

PLACEBO COMPARATOR

Control group given equal volume of saline with the dexmedetomidine group.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is common used to improve the prognosis and life quality of patients.

Also known as: Dexmedetomidine is a highly selective α2-adrenoceptor agonist.

Dexmedetomidine group

Saline DRUG

It is safe Placebo.

Also known as: It is safe Placebo.

Saline group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

Anesthesiology department of General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhihua Wang, M.D.

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: February 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

CN (1)