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Premediacation with single dose of Acetazolamid for the control of referred shoulder pain after laparoscopic cholecystectomy

Protocol summary

Summary
Post laparscopic Shoulder pain is a common problem. It is assumed Acetazolamide prevents the occurrence of shoulder pain in the postoperative period. The reason is that, Acetazolamide prevents compounding of carbon dioxide with water which decreases sub diaphragmatic fluid acidity and cause referred shoulder pain Seventy patients who are candidates for the laparoscopic Cholecystectomy, after written consent randomly are placed in the two equal groups (Acetazolamide group and the control group). Main inclusion criteria are patients undergoing laparoscopic cholecystectomy in rang 0f 30-60 years old. And some of exclusion criteria are: Sensitivity to sulfonamides, Renal and Hepatic failer, psychopathic patients, addiction, previous acidosis.The first group was given Acetazolamide 5mg/kg one hour before surgery by oral route, while the second group didn't received any drugs All patients Premedicated by midazolam /05mg/kg and Fentany lμg/kg then Induction by Propofol 2mg/kg and Atracorium/.8 mg/kg were performed. After intubation, Maintenance of anesthesia continued by Isoflurane and N2O. All subsequent stages of anesthesia are similar in both groups. At the end of surgery and after awaking severity pain and analgesic consumption are recorded in (awaking) time 0, 2,4, 6, 12 and 24 hours post operative. And at the end of the study the results analyzed and compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407111772N15
Registration date: 2014-07-19, 1393/04/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research / Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Premediacation with single dose of Acetazolamid for the control of referred shoulder pain after laparoscopic cholecystectomy
Public title
Post laparascopy shoulder pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing laparoscopic cholecystectomy in rang of 30-60 years old. Exclusion criteria:1- addiction 2-psychopathic patients 3- patient avoidance 4-previous pain full disease 5-Sensitivity to sulfonamides 6- renal failer 7-COPD and lung disease8-pregnancy 9-hematologic disorder 10- previous acidosis 11- renal implantation 12-exitance of electrolyte imbalance 13- previous Lithium consumption 14- CNS disorder 15-Hepatic disorder16-use of other diuretics 17-previous shoulder pathology 18- previous muscle disease 19- hypoglycemia
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical science , reseach ethical committee
Street address
Daneshghah street/ Tabriz university of medical science/ Vice chancellor of reseach/ ethical committee
City
Tabriz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
9273

Health conditions studied

1

Description of health condition studied
post laparascopy shoulder pain
ICD-10 code
T50.2
ICD-10 code description
Carbonic-anhydrase inhibitors

Primary outcomes

1

Description
Pain
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Opioid cosumption
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Total Dose

Intervention groups

1

Description
Acetazolamide 5mg/kg one hour before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Imam Reza Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical science/ Vice chancellor of reseach
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical science/ Vice chancellor of reseach
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
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin Tabriz
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
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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