A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy

This study is currently recruiting participants.
Verified August 2012 by Anhui Medical University
Sponsor:
Information provided by (Responsible Party):
Yun Li, Anhui Medical University
ClinicalTrials.gov Identifier:
NCT01657812
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Dexmedetomidine is a potent α2-adrenoceptor agonist with an 8 times greater affinity for α2-adrenoceptors than clonidine. This class of agent is known to have sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.1 Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage. The investigators hypothesize that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.


Condition Intervention Phase
Gastrectomy
Drug: dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy

Resource links provided by NLM:


Further study details as provided by Anhui Medical University:

Primary Outcome Measures:
  • Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E) [ Time Frame: pre-administration of Dex or epidural anesthesia,intubation, 3 min after intubation , immediately after incision, immediately after the initiation of celiac exploration, 1 h after operation,extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anesthetics consumption: propofol and remifentanil consumption [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
  • anesthesia recovery :the time of eye opening, side effects such as nausea, vomiting and post-anaesthetic shivering, VAS, first exhaust time, hospitalization time [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexmedetomidine
Drug:dexmedetomidine,dexmedetomidine 1.0μg/kg intravenous injection within 15 minutes before the induction of general anesthesia and followed by Dex 0.4μg/kg/h until 40min before the end of surgery
Drug: dexmedetomidine

Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage.

Date suggest that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.

Other Name: epidural
Active Comparator: epidural
Epidural:continuous epidural block (T8-9) 4 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery
Drug: dexmedetomidine

Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage.

Date suggest that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery.

Other Name: epidural
Placebo Comparator: control
Drug: normalsaline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent
  • ASA 1-2
  • No contraindication to epidural or dexmedetomidine
  • First time surgery for current conditions
  • Not on chronic pain medications or sedative

Exclusion Criteria:

  • .The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests

    • The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
    • The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine
    • The subject has know central nervous system disease or neurological impairment
    • The subject is an ASA classification of 3 or greater
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657812

Locations
China, Anhui
The Second Affiliated Hospital of Anhui Medical University Recruiting
HeFei, Anhui, China, 230601
Contact: Yun Li, doctor       yunli_001@yahoo.com.cn   
Contact: Ye Zhang, doctor       zhangye_hassan@yahoo.com.cn   
Sponsors and Collaborators
Anhui Medical University
Investigators
Principal Investigator: Ye Zhang, Ph.D The Second Affiliated Hospital of Anhui Medical University
  More Information

Publications:
Responsible Party: Yun Li, Head of department of Anesthesiology in the Second Affiliated Hospital of Anhui Medical University, Anhui Medical University
ClinicalTrials.gov Identifier: NCT01657812     History of Changes
Other Study ID Numbers: 3869480
Study First Received: August 2, 2012
Last Updated: August 3, 2012
Health Authority: China: Ethics Committee

Keywords provided by Anhui Medical University:
dexmedetomidine
Epidural Anesthesia
stress response
anesthesia recovery

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014