To determine the effect of acupuncture on hemodynamic stability and postoperative nausea and pain in laparoscopic cholecystectomy
Design
A randomized, double blinded clinical trial with two arm parallel groups
Settings and conduct
The patients are receiving fentanyl, midazolam and lidocaine and then propofol and atracurium as induction and maintained by propofol. Needles are inserted on 5 acupoints LI4, P6, GB34, Liv2, St36 after intubation and will be maintained for 20 minutes after the acupuncture. The mean arterial pressure and the heart rate will be measured before induction, 2 minutes after intubation, immediately before and 5, 30, 60, 90 and 120 minutes after gas insufflation. The severity of pain and nausea and incidence of vomiting will be evaluated respectively by NRS and likert scale and by asking the patient after surgery in the post operative care unit and 6 hours later. Considering the participants are unconscious before needling so they are blinded. Data collector and outcome assessor are also blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates of laparoscopic cholecystectomy
Exclusion criteria: Being pregnant , Past medical history of hypertension ,
No access to acupuncture points
Intervention groups
The patients considered for laparoscopic cholecyctectomy who are older than 18 and not pregnant are included in our research. Needles are going to be inserted after induction and intubation. The mean arterial pressure (MAP) and the heart rates (HR) of the patient will be measured during the surgery. The evaluation of the severity of pain and nausea and the incidence of vomiting will be after the surgery.
the method of anesthesia and the variables in the control group, who are not being needled, are same as the interventional group.
Main outcome variables
Mean arterial pressure; Heart rate variability; Pain; Nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101026005026N11
Registration date:2019-12-16, 1398/09/25
Registration timing:registered_while_recruiting
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-23, 1398/09/02
Expected recruitment end date
2020-06-22, 1399/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture on hemodynamic stability and postoperative nausea and pain in laparoscopic cholecystectomy
Public title
The effect of acupuncture on hemodynamic stability and postoperative nausea and pain in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates of laparoscopic cholecystectomy
Exclusion criteria:
Being pregnant
Past medical history of hypertension
No access to acupuncture points
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Random number generator on calculator
Random numbers will be generated on a calculator. If the generated number is even, it will be allocated to the interventional group. Otherwise, it will be allocated to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be informed about possibility of receiving acupuncture on the identified acupoints before receiving anesthesia. Considering the participants are unconscious, they are not aware of being in interventional or control group. Data collector and outcome assessor are blinded to the fact that patients have received acupuncture or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.IUMS.FMD.REC.1398.342
Health conditions studied
1
Description of health condition studied
pain after laparoscopic cholecystectomy
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
nausea and vomiting after laparoscopic cholecystectomy
ICD-10 code
R11
ICD-10 code description
nausea and vomiting
Primary outcomes
1
Description
Mean arterial pressure variability
Timepoint
Before induction of anesthesia, 2 minutes after intubation, immediately before and 5, 30, 60, 90 and 120 minutes after gas insufflation for laparoscopic cholecystectomy
Method of measurement
non invasive Blood pressure monitoring
2
Description
Heart rate variability
Timepoint
Before induction of anesthesia, 2 minutes after intubation, immediately before and 5, 30, 60, 90 and 120 minutes after gas insufflation for laparoscopic cholecystectomy
Method of measurement
Heart rate monitoring
Secondary outcomes
1
Description
pain
Timepoint
to determine the severity of pain after laparoscopic cholecystectomy in recovery room and 6 hours later in the ward
Method of measurement
Numerical rating scale
2
Description
nausea
Timepoint
to determine the severity of nausea after laparoscopic cholecystectomy in recovery room and 6 hours later in the ward
Method of measurement
likert scale
Intervention groups
1
Description
Intervention group: Acupuncture for 20 minutes at LI4, P6, GB34, Liv2, St36
Category
Treatment - Other
2
Description
Control group: There was no acupuncture
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Masood Mohseni
Street address
Niaysh Ave., Sattar khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Email
Masood.mohseni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
َAbbas Motevalian
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Fax
+98 21 6435 2328
Email
Masood.mohseni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Fax
+98 21 6435 2328
Email
Masood.mohseni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sharareh Barband
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2326
Fax
+98 21 6435 2328
Email
sharareh.barband@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary and secondary outcomes
When the data will become available and for how long
Immediately after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
The result of futher analysis may not be presented to public without permission
From where data/document is obtainable
Masood.mohseni@gmail.com
What processes are involved for a request to access data/document
A resonable request from an academic source will be responded within 10 working days