Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01657812
Other study ID # 3869480
Secondary ID
Status Recruiting
Phase Phase 4
First received August 2, 2012
Last updated August 3, 2012
Start date July 2012
Est. completion date July 2013

Study information

Verified date August 2012
Source Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dexmedetomidine
Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition a2-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.

Locations

Country Name City State
China The Second Affiliated Hospital of Anhui Medical University HeFei Anhui

Sponsors (1)

Lead Sponsor Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Anesthetics consumption: propofol and remifentanil consumption during operation Yes
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Active, not recruiting NCT04422236 - A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Completed NCT00827931 - Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery Phase 4
Completed NCT01257711 - A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer N/A
Not yet recruiting NCT06062225 - Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy N/A
Completed NCT00885781 - Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT Phase 4
Not yet recruiting NCT05071755 - Gastrectomy Outcomes in Elderly Patients
Recruiting NCT04798820 - The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING) N/A
Not yet recruiting NCT04191564 - Effect of Anesthetic Conditions on Stapling Thickness and Quality N/A
Recruiting NCT04295473 - Reduced Port Laparoscopic Gastrectomy for Gastric Cancer N/A
Recruiting NCT02068833 - Resolution of Microalbuminuria and Dysmetabolism Following Bariatric Surgery: Prospective Study N/A
Recruiting NCT01142271 - Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy Phase 3
Completed NCT03939819 - Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy N/A
Withdrawn NCT00622804 - Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy Phase 3
Recruiting NCT03708783 - Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC N/A
Recruiting NCT06403540 - The Impact of Laparotomy and Analgesia Methods on Diaphragm
Completed NCT03436082 - Post-Market Surveillance With a Novel mHealth Platform
Recruiting NCT06058442 - The Pancreatic Enzymes After Gastrectomy Trial Phase 3
Terminated NCT02836353 - Metabolic Consequences of Gastrointestinal Surgery N/A
Unknown status NCT02503826 - The Efficacy and Optimal Dose of Sufentanil in Patient Controlled Analgesia After Moderate Surgery Phase 4