UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Title of the study (Brief title)	Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Region	Japan

Condition
Condition	Patients underwent bilateral tonsillectomy
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the parameters and methods reflecting surgical invasiveness induced by tonsillectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Parameters of Pupil light reflex (PLR) and Heart rate variability (HRV) at two times before tonsillectomy and POD1, 2 and 2-4 weeks. Pupil: initial diameter, minimum diameter, latency, max constriction velocity, averaged constriction velocity, constriction ratio, averaged dilation velocity, 4 different stimulus intensity (10,50,121,180) HRV: LF norm, HF norm, LF/HF
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	10 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients underwent bilateral tonsillectomy
Key exclusion criteria	1) Patients required post surgical hemostasis for severe bleeding 2) Patients with severe central neural disorders and cardiac disorders. 3) Patients whom doctors judge as an inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	MASAAKI ISHIKAWA
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
Address	Amagasaki city higashinanbacho 2chome 17-77
TEL	06-6480-7000
Email	aimaruko@gmail.com

Public contact
Name of contact person	MASAAKI ISHIKAWA
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
Address	Amagasaki city higashinanbacho 2chome 17-77
TEL	06-6480-7000
Homepage URL
Email	aimaruko@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization	Hyogo Prefectural Amagasaki General Medical Center
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	2019 Year 02 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 31 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date
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	Prospective cohort study

Management information
Registered date	2019 Year 02 Month 21 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040959