Protocol summary

Summary
Objectives: To compare the two doses of intravenous lidocaine on pain and nausea-vomiting after surgery of Stomach Bypass with Laparascopy Design: 40 patients admitted to hospital for Laparascopy then they divided into two groups. Intravenous lidocaine infusion at doses of 1 mg and 2 mg, according to each group, were taken during surgery. Then pain, nausea-vomiting, both static and dynamic in PACU and surgical ward at zero, half an hour, one and six and twelve and twenty-four hours and agitation rate, systolic and diastolic blood pressure and heart rate in both groups A, B at time zero, half an hour and one hour after the operation compared. Inclusion criteria: patient consent, age greater than 18 and less than 60 years; BMI less than 50; ASA equal to or less than 3; Intraoperative lidocaine infusion time up to 4 hours; no sensitivity to lidocaine; no heart diseases; no liver diseases; no kidney diseases; no psychiatric diseases; Avoiding the use of alcohol and drugs addiction Exclusion criteria: Withdraw from the study; Intraoperative lidocaine infusion time more 4 hours; conversion laparoscopy to laparotomy Interventions include: Intravenous infusion of lidocaine during surgery with values of 1 mg / kg / h and / kg / h 2 mg The main outcome variables were: pain, nausea-vomiting, both static and dynamic in PACU , agitation rate, systolic blood pressure, diastolic blood pressure and heart rate after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121924754N2
Registration date: 2015-12-26, 1394/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-26, 1394/10/05
Registrant information
Name
Neda Hajiha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3615
Email address
nedahajiha94@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intravenous infusion of lidocaine with of 1 mg / kg / h and 2mg/ kg / h on reducing pain and nausea-vomiting after surgery of Stomach Bypass with Laparascopy
Public title
The effect of intravenous infusion of lidocaine during surgery on pain and nausea-vomiting in Stomach Bypass with Laparascopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient consent, age greater than 18 and less than 60 years; BMI less than 50; ASA equal to or less than 3; Intraoperative lidocaine infusion time up to 4 hours; no sensitivity to lidocaine; no heart diseases; no liver diseases; no kidney diseases; no psychiatric diseases; Avoiding the use of alcohol and drugs addiction Exclusion criteria: Withdraw from the study; Intraoperative lidocaine infusion time more 4 hours; conversion laparoscopy to laparotomy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Hemmat highway, next to Milad Hospital
City
Tehran
Postal code
Approval date
2014-12-03, 1393/09/12
Ethics committee reference number
4273/105/د/93

Health conditions studied

1

Description of health condition studied
Relation between effect of intravenous infusion of lidocaine during and after surgery on pain and nausea-vomiting in Stomach Bypass with Laparascopy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
At zero, half an hour, one and six and twelve and twenty-four hours
Method of measurement
V.A.S

2

Description
Nausea-vomiting
Timepoint
At zero, half an hour, one and six and twelve and twenty-four hours
Method of measurement
Asking of patient

3

Description
Systolic blood pressure
Timepoint
At time zero, half an hour and one hour after the operation
Method of measurement
Mercury sphygmomanometer

4

Description
Diastolic blood pressure
Timepoint
At time zero, half an hour and one hour after the operation
Method of measurement
Mercury sphygmomanometer

5

Description
Heart Rate count
Timepoint
At time zero, half an hour and one hour after the operation
Method of measurement
Pulse Rate count

Secondary outcomes

empty

Intervention groups

1

Description
Intravenous lidocaine infusion at doses of 1 mg /kg/hour
Category
Treatment - Drugs

2

Description
Intravenous lidocaine infusion at doses of 2 mg /kg/hour
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Rasool (S) Educational-Therapeutic Centre
Full name of responsible person
Dr. A.E Abedian
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyyed Ali Javad Mousavi, MD
Street address
Shahid Hemmat Highway, next to Milad Hospital
City
Tehran
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, Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Dr. AE Abedian
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh St. Sattarkhan St.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
amir_abedian2001@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahzad Alimian
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh St. Sattarkhan St.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
mahzadalimian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. AE Abedian
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh St. Sattarkhan St.
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
amir_abedian2001@yahoo.com
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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