NCT02569905

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 1, 2015

Last Update Submit

October 23, 2015

Conditions

Postoperative Shivering

Keywords

flurbiprofenParecoxib sodiumPostoperative Shivering

Outcome Measures

Primary Outcomes (1)

  • shivering

    in one hour after extubation.

Secondary Outcomes (3)

  • visual analogue score

    at the time of extubation, 30min and 60min after extubation.

  • sedation scores

    at the time of extubation, 30min and 60min after extubation.

  • incidence of postoperative nausea and vomiting

    in one hour after extubation.

Study Arms (3)

Groups Parecoxib sodium

ACTIVE COMPARATOR

Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.

Drug: parecoxib sodium

Groups Flurbiprofen

ACTIVE COMPARATOR

Fifty-two, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.

Drug: flurbiprofen

Group Saline

PLACEBO COMPARATOR

Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.

Drug: saline

Interventions

parecoxib sodiumDRUG

parecoxib sodium 40mg

Groups Parecoxib sodium
flurbiprofenDRUG

flurbiprofen 50mg

Groups Flurbiprofen
salineDRUG

normal saline

Group Saline

Eligibility Criteria

Age21 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department, Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (11)

  • Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. doi: 10.1093/bja/84.5.615. No abstract available.

    PMID: 10844839BACKGROUND

  • Kilbas Z, Mentes MO, Harlak A, Yigit T, Balkan SM, Cosar A, Ozturk 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. doi: 10.3906/sag-1402-125.

    PMID: 26281342BACKGROUND

  • 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.

    PMID: 26025794BACKGROUND

  • 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.

    PMID: 26345202BACKGROUND

  • 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. doi: 10.1097/00000539-199810000-00010.

    PMID: 9768772BACKGROUND

  • 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.

    PMID: 24270900BACKGROUND

  • 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. No abstract available.

    PMID: 25335108BACKGROUND

  • 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.

    PMID: 25908099BACKGROUND

  • 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.

    PMID: 26342782BACKGROUND

  • 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.

    PMID: 25851018BACKGROUND

  • 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.

    PMID: 22890247BACKGROUND

MeSH Terms

Interventions

parecoxibFlurbiprofenSodium Chloride

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologists

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 7, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

CN(1)