UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Title of the study (Brief title)	Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Region	Japan

Condition
Condition	Patients who will have elective gynecologic surgery
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate an effect of Acetaminophen to prevent postoperative shivering
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of postoperative shivering
Key secondary outcomes	The score of postoperative shivering The change of intraoperative and postoperative core temperature The incidence of postoperative nausea and vomitting The values of pain intensity measured on visual analog scales

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	An administration of Acetaminophen dose: 15 mg/kg (max 1000 mg) duration of administration: 15 minutes timing: Primary dosage is performed just after an anesthetic induction. Secondary dosage is performed after 4 hours.
Interventions/Control_2	An administration of Saline dose: 1.5 ml/kg (max 100 ml) duration of administration: 15 minutes timing: Primary dosage is performed just after an anesthetic induction. Secondary dosage is performed after 4 hours.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who will have elective, gynecologic abdominal surgery Predicted surgical time is over 2 hour Patients' physical status(ASA) are 1 or 2 Patients without an impaired liver function Patients without disturbance of consciousness
Key exclusion criteria	Insufficient record and measurement Patients who refuse to participate this study Patient with suspicion of allergy of Acetaminophen Patient with acute toxicity of Lidocaine or Ropivacaine Patient require critical care and mechanical ventilation in ICU after surgery Patient who is determined to be excluded from the study due to any reason by the study doctor
Target sample size	96

Research contact person
Name of lead principal investigator	Manabu Kakinohana
Organization	University of the Ryukyus
Division name	Department of Anesthesiology, Faculty of Medicine
Address	Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL	0988952221
Email	anesthks@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Takahiro Tadokoro
Organization	University of the Ryukyus
Division name	Department of Anesthesiology, Faculty of Medicine
Address	Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL	0988952221
Homepage URL
Email	rover2727@yahoo.co.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 03 Day
Last follow-up date	2017 Year 08 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 02 Day
Last modified on	2017 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023115