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

Anhui Medical University

Status and phase: Unknown; Phase 4

Conditions: Gastrectomy

Treatments: Drug: dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01657812

3869480

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine

epidural

Active Comparator group

Description:

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

Treatment:

Drug: dexmedetomidine

control

Placebo Comparator group

Description:

Drug: normalsaline