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Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering

Tumor Hospital of Guangxi Medical University, China

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02569905
Enrollment
166
Registered
2015-10-07
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Shivering

Keywords

flurbiprofen, Parecoxib sodium, Postoperative Shivering

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.

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.

Interventions

parecoxib sodium 40mg

DRUGflurbiprofen

flurbiprofen 50mg

DRUGsaline

normal saline

Sponsors

Guangxi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 62 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
shiveringin one hour after extubation.

Secondary

MeasureTime frame
visual analogue scoreat the time of extubation, 30min and 60min after extubation.
sedation scoresat the time of extubation, 30min and 60min after extubation.
incidence of postoperative nausea and vomitingin one hour after extubation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026