Protocol summary

Summary
This research is done to examine the effect of N-acethylcystein on postoperative pain after laparascopic cholecystectomy. This research is randomized double blind controled clinical trial. Thirty patients with this inclusion criteria: 20-50 years old; candidate for laparascopic cholecystectomy; with ASA1(healthy patient without other disease) are selected and randomly divided in two groups. Exclusion criteria include previous abdominal surgery; known sensivity to N-acethylcystein; operation time more than two hours; any uncommon complication in surgery or in intubation; neuropsychiatric disease; chronic pain before surgery; addiction; pregnancy; lactation and other concurrent surgery. The used substance is N-acethylcysteine, its chemical compound is Acetamido-3-sulfanylpropanoic acid (C5H9NO3S) and is acethylated derivative of L-cysteine amino acid. The night before surgery, 1200mg oral N-acethylcysteine in the form of two effervescent tablets (600mg) dissolved in water, were given to the intervention group and the morning before operation, 3cc of intravenous N-cethylcystein(200mg/cc) that was equal to 600 mg, in 100cc normal saline in a 5 minute transfusion . The prescribtion duration is twice, the night before and the morning of surgery and no longer required to be prescribed. For the control group, two vitamin c effervescent tablets (placebo) dissolved in water, were given at night before surgery and 3cc distilled water in 100cc normal saline as placebo transfused in 5 minutes in the morning before surgery.The liquid volume in all syringes specified as number 1 and number 2 with 3cc fluid, only the researcher's colleague knows about this and to avoid observer bias, in double-blind study. The anesthesia plan is similar in all of the cases including premedication, induction, antiemetic (plasil), volatile anesthetics and administration of morphine (1mg/kg). Mechanical ventilation is set to low tidal volume (6-8 cc/Kg) and high respiratory rate (14-16/minute) to prevent chest pain(confounding factor) caused by ventilation of small lung. Small lung in laparascopy is induced by insufflation of Co2 into the abdominal cavity and its resulted low lung functional residual capacity . The blood pressure, heart rate, occurrence of nausea and vomiting and severity of pain (by visual analog scale) are evaluated during postoperative recovery consecutively 1, 2, 4, 8 and 12 hours after the surgery. The total amount of pethidine consumed within 24 hours after surgery in two groups is evaluated and compared. If the pain score is more than 5, 30 milligrams of pethidine is administered each 4 to 6 hours. The total duration of the study is 12 months. Results: The study findings show a reduction of pain, the need for opioid and less side effects. Other outcoms studied are The existing nausea, vomiting and blood pressure and pulse rate alterations after the surgery, in the above-mentioned intervals, and decrease the use of this drug to reduce pain and decline in using of pethidine.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014112120020N1
Registration date: 2015-10-28, 1394/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-28, 1394/08/06
Registrant information
Name
Shahram Seyfi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.seyfi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Science
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of N-acethylcystein on pain after laparascopic cholecystectomy
Public title
The effect of N- acethylcystein on pain treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-50 years old; candidate for laparascopic cholecystectomy; ASA class1(healthy patient without other disease). Exclusion criteria: previous abdominal surgery; known sensitivity to N- acethylcystein; operation time more than 2 hours; any uncommon complication in operation or in intubation; chronic pain before operation; neuropsychiatric disease; addiction; pregnancy; lactation and other concurrent surgery.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Babol University of Medical sciences
Street address
Ganjafrooz street, Babol
City
Babol
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
305670

Health conditions studied

1

Description of health condition studied
pain after laparascopic cholecystectomy
ICD-10 code
k80.2
ICD-10 code description
calculus of gallbladder without cholecystitis

Primary outcomes

1

Description
pain
Timepoint
in recovery and 1, 2, 4, 8, 12 and 24 hours after operation
Method of measurement
visual analog scale(VAS)

Secondary outcomes

1

Description
nausea and vomiting
Timepoint
In recovery and 1, 2, 4, 8, 12 and 24 hour after operation
Method of measurement
scale 0-4

Intervention groups

1

Description
The night before surgery, 1200mg oral N-acethylcysteine in the form of two effervescent tablets (600mg)dissolved in water were given to the intervention group and the morning before operation, 3cc of intravenous N-cethylcystein(200mg/cc) that was equal to 600 mg in 100cc normal saline in a 5 minute transfusion was injected to intervention group. The prescribtion duration is twice the night before and the morning of surgery and no longer required to be prescribed.
Category
Treatment - Drugs

2

Description
For the control group, two vit c effervescent tablets (placebo) dissolved in water, were given at night before surgery and 3cc distilled water in 100cc normal saline as placebo transfused in 5 minutes in the morning before surgery.The liquid volume in all syringes specified as number 1 and number 2 with 3cc fluid, only the researcher's colleague knows about this and to avoid observer bias, in double-blind study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mrs Shahrbanoo Khatami
Street address
Shahid Keshvari Bridge,Shahid Beheshti Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Science
Full name of responsible person
Dr Ali Bijani
Street address
Babol University of Medical Scince, Ganjafrooz Street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Babol University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol Universityof Medical Science
Full name of responsible person
Mrs Sedighe Soleimanian
Position
Anesthetist
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
dr.m.ebrahhmzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Shahram Seyfi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
ficu_ss@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol Universitof Medical Science
Full name of responsible person
Mrs Soleimanian
Position
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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