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Completed

NCT Number: NCT02569905

Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering

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.

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Key information

Age range

21 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesia Department, Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parecoxib Sodium

Drug

parecoxib sodium 40mg

Flurbiprofen

Drug

flurbiprofen 50mg

Saline

Drug

normal saline

Primary outcomes

  1. shivering

    Time frame: in one hour after extubation.

Secondary outcomes

  1. visual analogue score

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

  2. sedation scores

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

  3. incidence of postoperative nausea and vomiting

    Time frame: in one hour after extubation.

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

Tumor Hospital of Guangxi Medical University, China

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2015
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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