UMIN-CTR Clinical Trial

Basic information
Public title	The effect of intravenous Ketamine for postoperative pain after laparoscopic cholecystectomy
Acronym	The effect of Ketamine for postoperative pain
Scientific Title	The effect of intravenous Ketamine for postoperative pain after laparoscopic cholecystectomy
Scientific Title:Acronym	The effect of Ketamine for postoperative pain
Region	Japan

Condition
Condition	Patients undergoing laparoscopic cholecystectomy
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the effect of intravenous administration of Ketamine for postoperative pain in patients undergoing laparoscopic cholecystectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluating the postoperative pain by using Visual Analogue Scale (VAS).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Control group Manage the general anesthesia by TIVA(Total intravenous anesthesia),using propofol,remifentanil,fentanyl. Control the effect cite fentanyl concentration within 1-1.5 ng/ml at the end of the anesthesia.
Interventions/Control_2	Ketamine group Manage the general anesthesia as the control group. In this intervention group, also administer Ketamine 0.5 mg/kg intravenously before incision.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Man and female with the age between 20 to 75 years old. 2) Patients undergoing laparoscopic cholecystectomy
Key exclusion criteria	1) Patients having cerebrovascular disease, hypertention(systolic blood pressure over 160mmHg, diastolic blood pressure over 100mmHg), elevated intracranial pressure, severe heart failure. 2) Past medical histroy of convulsion. 3) Pregnant woman and woman having the possibility of pregnancy. 4) Obese patients with BMI over 35. 5) Patients excluded by the judge of principal investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoko Mae
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Anesthesiology
Zip code
Address	4-22-1 Nakano, Nakano-ku,Tokyo,Japan
TEL	03-5343-5611
Email	chikomae@sa2.so-net.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Mae
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Anesthesiology
Zip code
Address	4-22-1 Nakano, Nakano-ku,Tokyo,Japan
TEL	03-5343-5611
Homepage URL
Email	chikomae@sa2.so-net.ne.jp

Sponsor
Institute	Tokyo Metropolitan Police Hospital
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
Date of IRB	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 29 Day
Last modified on	2020 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028334