Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

Fang Luo

Status and phase: Completed; Phase 4

Conditions: Restlessness; Pain

Treatments: Drug: dexmedetomidine; Drug: saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01517932

TJMU-A-201106

Details and patient eligibility

About

Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.

In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.

Full description

Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
• undergoing selective thoracotomy
• weight between 45 and 75kg
• operation time 2-4 hours

Exclusion criteria

• history of neurologic disease
• history of chronic analgesics intake
• history of allergic reactions to the experimental durgs
• history of renal insufficiency
• history of hepatic dysfunction
• history of coagulation disorders
• women in lactation
• participating in other studies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group-DEX

Experimental group

Description:

Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery

Treatment:

Drug: dexmedetomidine

Group-PLB

Placebo Comparator group

Description:

Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery

Treatment:

Drug: saline placebo