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Postoperative ShiveringPhase 4NCT02569905

Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering

A Phase 4 study testing parecoxib sodium, flurbiprofen and saline in people with Postoperative Shivering, run by Guangxi Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 62 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Shivering
What is being tested?
parecoxib sodium, flurbiprofen and saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
1 siteChina
Study dates
Apr 2014to Apr 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 62 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Anesthesia Department, Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: Tumor Hospital of Guangxi Medical University, China

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.

Read the detailed 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.

Being tested
parecoxib sodium, flurbiprofen, saline
Keywords
flurbiprofen, Parecoxib sodium, Postoperative Shivering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • parecoxib sodiumDrug

    parecoxib sodium 40mg

  • flurbiprofenDrug

    flurbiprofen 50mg

  • salineDrug

    normal saline

Study groups in NCT02569905
Study groupRoleWhat they receive
Groups Parecoxib sodiumActive comparatorFifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
Receives: Drug: parecoxib sodium
Groups FlurbiprofenActive comparatorFifty-two, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
Receives: Drug: flurbiprofen
Group SalinePlacebo comparatorFifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. shivering

    Measured: in one hour after extubation.

Secondary outcomes (3)

  1. visual analogue score

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

  2. sedation scores

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

  3. incidence of postoperative nausea and vomiting

    Measured: in one hour after extubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569905
Sponsor's protocol ID
2014032605
Status last verified
Oct 2015
First submitted
1 Oct 2015
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10844839

  • 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.

    PubMed 26281342

  • 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.

    PubMed 26025794

  • 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.

    PubMed 26345202

  • 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.

    PubMed 9768772

  • 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.

    PubMed 24270900

  • 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.

    PubMed 25335108

  • 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.

    PubMed 25908099

  • 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.

    PubMed 26342782

  • 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.

    PubMed 25851018

  • 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.

    PubMed 22890247

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing parecoxib sodium, flurbiprofen and saline in people with Postoperative Shivering, run by Guangxi Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

shivering (time frame: in one hour after extubation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569905, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.

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