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Completed

NCT Number: NCT03025295

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology department of General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Dexmedetomidine is a highly selective α2-adrenoceptor agonist.

Saline

Drug

It is safe Placebo.

Other names: It is safe Placebo.

Primary outcomes

  1. orexin A concentrations

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2017
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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