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

NCT01657812 | Unknown Phase 4 DMC

• 1 other identifier: 3869480
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrectomy

Keywords

dexmedetomidine; Epidural Anesthesia; stress response; anesthesia recovery

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E)

  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

Secondary Outcomes (2)

• Anesthetics consumption: propofol and remifentanil consumption

  during operation

• anesthesia recovery :the time of eye opening, side effects such as nausea, vomiting and post-anaesthetic shivering, VAS, first exhaust time, hospitalization time

  up to 48 hours

Study Arms (3)

dexmedetomidine

EXPERIMENTAL

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

epidural

ACTIVE COMPARATOR

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

control

PLACEBO COMPARATOR

Drug: normalsaline

Interventions

dexmedetomidine DRUG

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.

Also known as: epidural

dexmedetomidine; epidural

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Related Publications (1)

• Kunisawa T, Nagata O, Nagashima M, Mitamura S, Ueno M, Suzuki A, Takahata O, Iwasaki H. Dexmedetomidine suppresses the decrease in blood pressure during anesthetic induction and blunts the cardiovascular response to tracheal intubation. J Clin Anesth. 2009 May;21(3):194-9. doi: 10.1016/j.jclinane.2008.08.015.

  PMID: 19464613 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Interventions

Dexmedetomidine; Injections, Epidural

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ye Zhang, Ph.D

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Anesthesiology in the Second Affiliated Hospital of Anhui Medical University

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

CN (1)