Comparison of analgesic and hemodynamic effects of morphine sulphate alone and morphine sulphate plus nitroglycerine in candidates for simple abdominal surgeries using intravenous patient-controlled analgesia
To examine the effect of adding nitroglycerin to morphine in patient-controlled analgesia pumps on the pain following simple abdominal surgeries
Design
A total of 60 candidates for simple abdominal surgeries will be assigned into case and control groups using the table of random numbers (30 patients per group).
Settings and conduct
The study is one-centered , single-blinded (on the part of participants), and in the second phase of clinical trials.
Participants/Inclusion and exclusion criteria
The major inclusion criteria are: patients with anesthesia classes 1 and 2; age from 18 to 50 years; and being candidate for simple elective abdominal surgery. The major exclusion criteria include addiction, history of using any kinds of sedatives or anti-nausea/vomiting drugs; and contraindication and sensitiveness to nitroglycerin drugs and morphine.
Intervention groups
Without receiving any pre-anesthetics, both groups undergo the required monitoring and examinations in the operating room, including the measurement of systolic and diastolic blood pressure in a non-invasive manner; the measurement of arterial oxygen; pulse oximetry; and electrocardiogram recording. Patients in the two groups undergo general anesthesia in a similar manner using 2 milligram/kilogram propofol and 3 microgram/kilogram fentanyl , as well as 0.5 milligram/kilogram muscle relaxant with a tracheal tube of appropriate size. After the surgery is completed and the patient is transferred to the recovery unit, the intravenous pain pump in the control group will be filled with morphine 0.75 milligram/kilogram, and it will be filled in the case group with morphine 0.5 milligram/kilogram plus 3 microgram/minute nitroglycerin; normal saline will be used in order to fill up the remaining volume of the pump up to 100 cc, and then it will be attached to the patient by inserting a separate vein with angiocatheter No. 20.
Main outcome variables
Hemodynamic parameters, nausea, vomiting and pain will be measured using the visual analogue scale, and sedation will be measured based on Ramsay scale immediately, 2, 6, 12 and 24 hours after operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N33
Registration date:2018-01-27, 1396/11/07
Registration timing:registered_while_recruiting
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic and hemodynamic effects of morphine sulphate alone and morphine sulphate plus nitroglycerine in candidates for simple abdominal surgeries using intravenous patient-controlled analgesia
Public title
The effect of adding nitroglycerin to morphine in intravenous pain control pumps
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anesthesia classes 1 and 2
age from 18 to 50 years
candidate for simple elective abdominal surgery (herniorrhaphy, cholecystectomy, jejunoileostomy) with surgery duration below two hours
bleeding volume less than 200 cc
length of incision below 10 centimeters
Exclusion criteria:
Addiction
history of using any kinds of sedatives or anti-nausea/vomiting drugs
contraindication and sensitiveness to nitroglycerin drugs and morphine
incidence of side-effects such as hypotension, headaches, nausea/vomiting, or arrhythmia requiring treatment during the use of pumps
cases of turning surgeries into complex ones
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not aware of which study group they are allocated into.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari St.,
City
Birand
Province
South Khorasan
Postal code
9717853577
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.bums.REC.1395.194
Health conditions studied
1
Description of health condition studied
Post-operative pain
ICD-10 code
G89.28
ICD-10 code description
Other chronic postprocedural pain
Primary outcomes
1
Description
Pain
Timepoint
Immediately, 2, 6, 12 and 24 hours after operation
Method of measurement
Visual Analogue Scale
2
Description
Systolic and diastolic blood pressure
Timepoint
Immediately, 2, 6, 12 and 24 hours after operation
Method of measurement
Saadat Company Monitoring Device
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
Immediately, 2, 6, 12 and 24 hours after operation
Method of measurement
Examination
Intervention groups
1
Description
Intervention group: (Morphine + Nitroglycerin): Intravenous pain pump of the case group will be filled with 0.5 milligram/kilogram morphine + 3 microgram/minute nitroglycerin.
Category
Prevention
2
Description
Control group: (morphine): Intravenous pain pump in the control group will be filled with 0.75 milligram/kilogram morphine .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating Room of Imam Reza Hospital
Full name of responsible person
Dr Seyed Hasan Karbasy
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Email
shkarbasy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 2000
Email
drtoobakazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
50
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
Birjand University of Medical Sciences
Full name of responsible person
Dr Azadeh Sekhavati
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Email
roozgar@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Seyed Hasan Karbasy
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Email
shkarbasy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
roozgar@BUMS.ac.ir
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
The majority of participants agreed to participate if the confidentiality of data would be guaranteed.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Informed Consent for Participation
When the data will become available and for how long
Unlimited
To whom data/document is available
Any researcher
Under which criteria data/document could be used
To complete and to express viewpoints
From where data/document is obtainable
The official website of Vice-chancellery for Research of Birjand University of Medical Sciences
What processes are involved for a request to access data/document