Clinical trial NCT01657812: A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy
Official title: A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastrectomy
Keywords: dexmedetomidine
Epidural Anesthesia
stress response
anesthesia recovery
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cardiovascular Parameters: Heart rate, blood pressure and ECG ;Parameters on stress response:norepinephrine (NE), epinephrine ( E)
timeFrame: 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:
measure: Anesthetics consumption: propofol and remifentanil consumption
timeFrame: during operation
measure: anesthesia recovery :the time of eye opening, side effects such as nausea, vomiting and post-anaesthetic shivering, VAS, first exhaust time, hospitalization time
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: HeFei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Ye Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.