Protocol summary

Summary
(1) Objectives: the purpose of this study is evaluation of analgesic effects of intravenous infusion of Lidocaine and Ketamine during surgery on acute pain after elective laparotomy surgery. (2) Design: this study is a double-blind randomized controlled trial and will be accomplished in Hazrat-e-rasool akram hospital in Tehran, Iran between 2013 and 2014. This trial is a phase III study. The participants are 80 patients, both male and female.The patients will be divided in two groups based on random number table. In one group Lidocaine and Ketamine will be infused during surgery and in the other group general anesthesia will just be induced. (3) Setting and conduct: in one group after induction of general anesthesia, intravenous Lidocaine and Ketamine will be infused during surgery with assigned doses. In the other group general anesthesia will just be induced. (4) Inclusion criteria: ASA I, ASA II, Hb>10, age between 20 and 60. Exclusion criteria: hemodynamic instability, uncontrolled underlying disease, drug sensitivity, addiction to alcohol and opioids. (5) Intervention: in one group, 30 minutes after induction of general anesthesia, both drugs Lidocaine and Ketamine will be infused intravenously with the dose of 0.5 mg/kg/hr until termination of surgery. In the other group these drugs will not be infused and general anesthesia will just be induced. (6) Main outcome measures: for evaluation of efficacy of intervention on rate of pain, visual analogue scale (VAS) will be used. Side effects including cardiac arrhythmia, seizure, halucination, delirium, and drug sensitivity will be evaluated in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017071935187N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Alireza Bagheri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 86709
Email address
a.bagheri.iums@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesic effects of intravenous infusion of Lidocaine and Ketamine during surgery on acute pain after elective laparotomy surgery.
Public title
Comparison of analgesic effects of intravenous infusion of Lidocaine and Ketamine on acute pain after elective laparotomy surgery in patients of two groups of purpose and control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I, ASA II, Hb>10, elective laparotomy surgery, consent to participation, no important underlying disease. Exclusion criteria: uncontrolled underlying disease, addiction to alcohol and opioids, sensitivity to opioids, Ketamine or Lidocaine, weight>115kg, height<140cm.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
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

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Near Milad tower, Shahid Hemmat Hwy.
City
Tehran
Postal code
1449614535
Approval date
2014-09-14, 1393/06/23
Ethics committee reference number
105/2891/د/93

Health conditions studied

1

Description of health condition studied
Acute pain after elective laparotomy surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute post-procedural pain

Primary outcomes

1

Description
Comparison of acute pain after elective laparotomy surgery
Timepoint
Just after surgery, 6 hrs after surgery, 12 hrs after surgery, 18 hrs after surgery, 24 hrs after surgery
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Seizure
Timepoint
Any time after beginning of signs & symptoms
Method of measurement
Patient and support person's complaint

2

Description
Cardiac arrhythmia
Timepoint
Any time after beginning of signs & symptoms
Method of measurement
Patient and support person's complaint and ECG

3

Description
Halucination
Timepoint
Any time after beginning of signs & symptoms
Method of measurement
Patient and support person's complaint

4

Description
Nausea & Vomiting
Timepoint
Any time after beginning of signs & symptoms
Method of measurement
Patient and support person's complaint

5

Description
Delirium
Timepoint
Any time after beggining of signs and symptoms
Method of measurement
Patient and support person's complaint

6

Description
Drug sensitivity
Timepoint
Any time after beginning of signs & symptoms
Method of measurement
Patient and support person's complaint

Intervention groups

1

Description
In the intervention group, 30 minutes after beginning of surgery, both drugs of Lidocaine and Ketamine will be infused intravenously for patients with the dose of 0.5 mg/kg/hr till end of surgery.
Category
Treatment - Drugs

2

Description
In the control group Lidocaine and Ketamine will not be infused for patients and general anesthesia will just be induced
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Dr. Farnad Imani, full profesor of anesthesiology
Street address
Rasool Akram hospital, Niyayesh Ave, Sattarkhan Blvd
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
Dr. Alijavad Musavi
Street address
Iran University of Medical Sciences, Near Milad tower, Shahid Hemmat Hwy
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. Farnad Imani
Position
Full profesor of anesthesiology
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Near Milad hospital, Shahid Hemmat Hwy
City
Tehran
Postal code
1449614535
Phone
+98 21 6651 5758
Fax
Email
Farnadimani@yahoo.com
Web page address
www.anesth.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farnad Imani
Position
Full profesor of anesthesiology
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Near Milad tower, Shahid Hemmat Hwy
City
Tehran
Postal code
1449614535
Phone
+98 21 6651 5758
Fax
Email
Farnadimani@yahoo.com; a.bagheri.iums@gmail.com
Web page address
www.anesth.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Bagheri
Position
General practitioner
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Near Milad Tower, Shahid Hemmat Hwy
City
Tehran
Postal code
1449614535
Phone
+98 21 6651 5758
Fax
Email
a.bagheri.iums@gmail.com
Web page address
www.iums.ac.ir

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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