Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering

Postoperative Shivering Clinical Trial

Official title:

Tumor Hospital of Guangxi Medical University, China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569905
• Other study ID #: 2014032605
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2015
• Last updated: October 23, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangxi Zhuang Autonomous Region
• Study type: Interventional

Clinical Trial Summary

Shivering is an early postoperative complication during the postoperative recovery period, and there is no clear consensus about the best way for its prevention. The aim of the study was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with that of parecoxib or placebo for reducing postoperative shivering.

Description:

154 patients with American Society of Anesthesiologists physical status I-II, who were scheduled for colorectal operation under general anesthesia, were randomly assigned to receive flurbiprofen (Group F), parecoxib sodium (Group P ) or normal saline(Group S)40min before the end of surgery. Hemodynamic parameters were monitored. The occurrence of shivering postoperative nausea and vomiting were recorded during the recovery period. And visual analogue score (VAS) and ramsy sedation scale (RSS) were also recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 62 Years

Eligibility

Inclusion Criteria:

• One hundred and sixty-six, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the prospective, randomized, double-blind clinical study.

• All patients who were from 21 to 62 years old and body mass index 19-35 in tumor hospital of Guangxi medical university (State of China) from April 2014 to April 2015 were included.

Exclusion Criteria:

• Patients with cardiac, pulmonary, hepatic, renal, thyroid, or neuromuscular disease, and those who took chronic drug or abused alcohol were excluded.

• Another patients with hypertension, gastrointestinal bleeding, an initial core temperature >37.5? or <36.5?, a history of allergy to non- steroidal anti-inflammatory drugs (NSAIDs) or other agents to be used, and inability to cooperate were also excluded in this study.

• Another patients with blood loss during operation>400ml, a need for blood transfusion during surgery, duration of operation>4h and surgical procedures changed were excluded.

Study Design

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

Related Conditions & MeSH terms

• Postoperative Shivering

Intervention

Drug:
• parecoxib sodium
parecoxib sodium 40mg
• flurbiprofen
flurbiprofen 50mg
• saline
normal saline

Locations

Country	Name	City	State
China	Anesthesia Department, Tumor Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

Ayrian E, Kaye AD, Varner CL, Guerra C, Vadivelu N, Urman RD, Zelman V, Lumb PD, Rosa G, Bilotta F. Effects of Anesthetic Management on Early Postoperative Recovery, Hemodynamics and Pain After Supratentorial Craniotomy. J Clin Med Res. 2015 Oct;7(10):731-41. doi: 10.14740/jocmr2256w. Epub 2015 Aug 23. Review. — View Citation

Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. Review. — View Citation

Chen J, Chen Y, Lu KZ. Prophylactic parecoxib reduces the incidence of shivering after general anaesthesia. Eur J Anaesthesiol. 2014 Dec;31(12):714-5. doi: 10.1097/EJA.0000000000000165. — View Citation

Kilbas Z, Mentes MÖ, Harlak A, Yigit T, Balkan SM, Cosar A, Öztürk E, Kozak O, Tufan CT. Efficacy of wound infiltration with lornoxicam for postoperative analgesia following thyroidectomy: a prospective, randomized, double-blind study. Turk J Med Sci. 2015;45(3):700-5. — View Citation

Li X, Zhou M, Xia Q, Li W, Zhang Y. Effect of parecoxib sodium on postoperative shivering: a randomised, double-blind clinical trial. Eur J Anaesthesiol. 2014 Apr;31(4):225-30. doi: 10.1097/01.EJA.0000436684.94403.1e. — View Citation

Liu ZX, Xu FY, Liang X, Zhou M, Wu L, Wu JR, Xia JH, Zou Z. Efficacy of dexmedetomidine on postoperative shivering: a meta-analysis of clinical trials. Can J Anaesth. 2015 Jul;62(7):816-29. doi: 10.1007/s12630-015-0368-1. Epub 2015 Apr 8. Review. — View Citation

Park SM, Mangat HS, Berger K, Rosengart AJ. Efficacy spectrum of antishivering medications: meta-analysis of randomized controlled trials. Crit Care Med. 2012 Nov;40(11):3070-82. doi: 10.1097/CCM.0b013e31825b931e. Review. — View Citation

Shen H, Chen Y, Lu KZ, Chen J. Parecoxib for the prevention of shivering after general anesthesia. J Surg Res. 2015 Jul;197(1):139-44. doi: 10.1016/j.jss.2015.03.011. Epub 2015 Mar 28. — View Citation

Teymourian H, Mohajerani SA, Bagheri P, Seddighi A, Seddighi AS, Razavian I. Effect of Ondansetron on Postoperative Shivering After Craniotomy. World Neurosurg. 2015 Dec;84(6):1923-8. doi: 10.1016/j.wneu.2015.08.034. Epub 2015 Sep 3. — View Citation

Yang X, Peng N, Li N, Li J. Effect of cyclooxygenase-2-specific inhibitors on postoperative analgesia after major open abdominal surgery. Pain Manag Nurs. 2015 Jun;16(3):242-8. doi: 10.1016/j.pmn.2014.07.004. — View Citation

Yared JP, Starr NJ, Hoffmann-Hogg L, Bashour CA, Insler SR, O'Connor M, Piedmonte M, Cosgrove DM 3rd. Dexamethasone decreases the incidence of shivering after cardiac surgery: a randomized, double-blind, placebo-controlled study. Anesth Analg. 1998 Oct;87(4):795-9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shivering		in one hour after extubation.	Yes
Secondary	visual analogue score		at the time of extubation, 30min and 60min after extubation.	Yes
Secondary	sedation scores		at the time of extubation, 30min and 60min after extubation.	Yes
Secondary	incidence of postoperative nausea and vomiting		in one hour after extubation.	Yes