Protocol summary

Summary
Purpose: Comparison of intraoperative blood pressure and heart rate changes, postoperative nausea, vomiting and pain in two methods of epidural and general anesthesia in laparoscopic cholecystectomy. Design and criteria: This study is prospective, randomized, double-blinded and clinical trial. 66 patients candidate for laparoscopic cholecystectomy were chosen and divided randomly to same groups. For the first group, general anesthesia (GA) and for the second group, epidural anesthesia is used. Methods and interventions: After monitoring, in the first group anesthesia is induced with fentanyl 4μg/kg, 0.5mg/kg atracurium and propofol 2mg/kg and is maintained by propofol infusion, atracurium and fentanil if needed. In the second group, patients are placed in the sitting position and using a 18-gauge tuohy needle, 15 mL of 0.5% hyperbaric bupivacaine is injected in the epidural space and the catheter inserted. Primary and secondary outcome: Blood pressure and heart rate were recorded before induction, after intubation in Group A, after catheter insertion and change the position in the second group and then every 15 minutes until the end of the surgery. After surgery, the incidence of abdominal and shoulder pain with VAS, nausea and vomiting in recovery room, 6, 12 and 24 hours later are evaluated. The onset time of pain and analgesic drug (methadone) are evaluated in the first 24 hours.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305289229N3
Registration date: 2013-06-17, 1392/03/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Mehryar Taghavi Gilani
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
taghavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2013-05-25, 1392/03/04
Expected recruitment end date
2014-05-25, 1393/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intraoperative blood pressure and heart rate changes, postoperative nausea, vomiting and pain in two methods of epidural and general anesthesia in laparoscopic cholecystectomy
Public title
Anesthesia in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I, II; laparoscopic cholecystectomy Exclusion criteria: patient,s refusal; coagulopathy; ischemic heart disease; heart failure; addiction; motion sickness; previous postoperative naseau and vomiting; increasing of surgery time due to adhesion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2013-05-25, 1392/03/04
Ethics committee reference number
910743

Health conditions studied

1

Description of health condition studied
intraoperative hemodynamic changes
ICD-10 code
I97.8
ICD-10 code description
Other postprocedural disorders of circulatory system, not elsewhere classified

2

Description of health condition studied
postoperative naseau and vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery

3

Description of health condition studied
postoperative pain
ICD-10 code
K91.8
ICD-10 code description
Other postprocedural disorders of digestive system, not elsewhere classified

Primary outcomes

1

Description
blood pressure
Timepoint
before of anesthesia and 15 minutes to end of surgery
Method of measurement
monitoring

2

Description
heart rate
Timepoint
before of anesthesia and 15 minutes to end of surgery
Method of measurement
monitoring

Secondary outcomes

1

Description
naseau
Timepoint
postoperation to 24 hours later
Method of measurement
observation and question

2

Description
vomiting
Timepoint
postoperation to 24 hours later
Method of measurement
observation and question

3

Description
abdominal pain
Timepoint
recovery room to 24 hours later
Method of measurement
verbal analogue scale

4

Description
shoulder pain
Timepoint
recovery room to 24 hours later
Method of measurement
verbal analogue scale

Intervention groups

1

Description
control group: the patients who receive general anesthesia
Category
Treatment - Drugs

2

Description
epidural group: the patients who receive epidural anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam-Reza Hospital
Full name of responsible person
Mehrya Taghavi Gilani
Street address
Department of Anesthesiology, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mehryar Taghavi Gilani
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine, Mashhad University Of Medical Sciences
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor
Other areas of specialty/work
Street address
Deparment of Anestesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
taghavim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
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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