A Comparison of Dexmedetomidine and Epidural Anesthesia Under General Anesthesia in Patients Undergoing Gastrectomy
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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 |
- 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 ]
- 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 |
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| 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 | |
| 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 May 16, 2013