Protocol summary

Study aim
Comparison of the effect of intraperitoneal dexmedetomidine or intravenous dexmedetomidine in combination with intraperitoneal bupivacaine on pain after laparoscopic cholecystectomy.
Design
Randomised,with a control group, parallel group trial with blinded outcome assesment, randomisation was done with random allocation software.
Settings and conduct
This study is a triple-blineded randomized clinical trial on 90 patients who are candidates for laparoscopic cholecystectomy in Al-zahra operating room at isfahan city. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients will be randomly assigned into 3 groups,in each group the intended intervention is applied and the patient's data and symptoms are recorded. In case of any change in anesthesia method and change of operation to open type, patients will be excluded from the study. The patients, the researcher who records the patient's symptoms, and the analysts who analyze the collected data don't know the type of intervention applied in each group and therefore they are all blind.
Participants/Inclusion and exclusion criteria
•Inclusion criteria: candidate patiants for laparoscopic cholecystectomy surgery, age between 18-65 years old, ASA I & II. •Excluision criteria: patients with a history of allergy to the drugs used in the study, patients with inability to express the intensity of pain based on the VAS criteria.
Intervention groups
Group 1: 20 ml bupivacaine 0.25% with dexmedetomidine at a dose of 1 μg/kg intraperitoneally, group 2: 20 ml bupivacaine 0.25% intraperitoneally and dexmedetomidine at a dose of 1 μg/kg iv.control group 22cc N/S intraperitoneal
Main outcome variables
vas pain score, dosage of additional analgesic, frequency of nausea & vomiting, palse rate, 02 saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N53
Registration date: 2023-07-08, 1402/04/17
Registration timing: prospective

Last update: 2023-07-08, 1402/04/17
Update count: 0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of adding intravenous dexmedetomidine or intraperitoneal dexmedetomidine to intraperitoneal bupivacaine on pain after laparoscopic cholecystectomy.
Public title
The effect of intravenous and intraperitoneal dexmedetomidine in combination with intraperitoneal bupivacaine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for laparoscopic cholecystectomy surgery ASA I & II(American society of anesthesiologist) Informed Consent to participate in the study
Exclusion criteria:
Patients with a history of allergy to the drugs used in the study (dexmedetomidine and bupivacaine) Patients with psychological problems Patients with a history of drug addiction Patients with the inability to express the intensity of pain based on the vas criterion
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the simple method , the samples are randomly placed in three intervention groups 1 and 2 and control by random allocation software. Sampling continues until the samples in all three groups reach the set limit.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a triple blind clinical trial,in this way, the patient is included in the study but does not know the type of intervention applied and is blind, the person who records the patient's symptoms is also different from the person who injects the drug And without knowing the type of drug, only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of School of Medicine-Isfahan university of Medical Sciences
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-04-24, 1402/02/04
Ethics committee reference number
IR.MUI.MED.REC.1402.051

Health conditions studied

1

Description of health condition studied
postoperative pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
the severity of postoperative pain
Timepoint
In base time9before intervention), every 15 minutes in recovery,in 2, 4, 6, 12, 24 hours after surgery.
Method of measurement
Visual Analogue Scale(0-10)

Secondary outcomes

1

Description
Mean arterial pressure
Timepoint
In base time(before intervention), every 30 minutes during operation and then in recovery
Method of measurement
barometer

2

Description
Heart Rate
Timepoint
In base time(before intervention), every 30 minutes during operation and then in recovery
Method of measurement
ECG

3

Description
Arterial blood oxygen saturation
Timepoint
In base time(before intervention), every 30 minutes during operation and then in recovery
Method of measurement
pulse oximeter

4

Description
complication(nausea and vomiting)
Timepoint
In base time(before intervention), every 30 minutes during operation and then in recovery
Method of measurement
asking

Intervention groups

1

Description
Intervention group1: In this group of patients who dont eat anything for at least 8 hours before the operation, 20 ml of bupivacaine 0.25% with 1 μg/kg of dexmedetomidine was injected intraperitonealy in the bedside of the gallbladder after the last clamp and just before the removal of the trocar of laparascope.
Category
Prevention

2

Description
Intervention group 2: In this group of patients who dont eat anything for at least 8 hours before the operation, at the end of the operation and after the last clamp and just before the removal of trocar of laparascope , 20 ml bupivacaine 0.25% intraperitoneally and 1 microgram/kg dexmedetomidine are injected into the patients.
Category
Prevention

3

Description
Control group: In this group, 22 cc of normal saline is injected intraperitoneally at the end of the operation to patients who have not eaten anything for at least 8 hours before the operation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad nazemoroaya
Street address
soffeh boulevard, shahid keshvari highway
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr mozhgan mortazavi
Street address
hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra molaei
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
,Alzahra hospital, soffeh boulevard, shahid keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2532
Email
Zmolaei78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, soffeh boulevard, shahid keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 31 822 2532
Email
Behzad_nazem@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, soffeh boulevard, shahid keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2532
Email
Behzad_nazem@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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