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Comparison of painless effects between ketamin and combinations of different doses of ketamin and bupivacaine after Percutaneous Nephrolithotripsi (PCNL) in patients with renal calculi.

Protocol summary

Summary
This study was done as a controlled randomized clinical trial. The aim of this study was reducing of pain and opium consumption after removing kidney stones through the subcutaneous duct. Fifty patients with 18-75 years old are suffering from kidney stones in self kidney were being randomly divided into 5 groups: The first group received intravenously 2 cc of normal saline (Amp Normal Saline 0.9%, Dena Pharmaceutical Co, Tabriz, Iran). The second group received intravenously 2 cc of bupivacaine 0.5% (Amp bupivacaine hydrochloride 0.5%, Astrazeneca Co, France) and 6 ml of distilled water (Vial 5 cc distilled water, Dena Pharmaceutical Co, Tabriz, Iran). The third group received intravenously 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5% (Vial Ketamin Hydrochloride 10ml, Rotexmedica Co, Germany). The fourth group received intravenously 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%. The fifth group received intravenously ketamine 5%, 1mg/kg at the end of surgery.The pain and narcotic use of patients was been assess and compare between five groups after extubation, leaving the recovery room and at the different hours of ward admission.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092612695N1
Registration date: 2013-10-14, 1392/07/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-14, 1392/07/22
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of painless effects between ketamin and combinations of different doses of ketamin and bupivacaine after Percutaneous Nephrolithotripsi (PCNL) in patients with renal calculi.
Public title
Comparison of painless effects between ketamin and combination of ketamin and bupivacaine in patient with renal calculi
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- 18-75 years. 2- Presence of calculi only in kidney itself. Exclusion criteria: 1- Drug abuser 2- Pregnancy 3- History of renal disease 4- Serum creatinine level more than 2mg/dl 5- History of uncontrolled Hypertension 6- History of psychological disorders and use of psychoactive drug
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This was a double-blind, 5-arm, parallel-group, placebo-controlled, randomized study. Four groups were consider the experimental treatment under study, while the one group was consider as a control group and was given a placebo. According to a table of random number, the patients were randomized to 1 of the following 5 treatment regimens. In this study, two groups of individuals involved in the trial did not know the identity of the intervention that is given to each participant. These two groups included the participants and the investigators in charge of assessing the outcomes of the interventions

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical sciences, Ghods st, Keshavarz blv.
City
Tehran
Postal code
66524185424
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
130-461-د-91

Health conditions studied

1

Description of health condition studied
Nephrolithiasis
ICD-10 code
N20.0
ICD-10 code description
Nephrolithiasis NOS

Primary outcomes

1

Description
Pain
Timepoint
5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after the patient has been transferred to the ward.
Method of measurement
Visual Analogue Scale

2

Description
Opioid consumption
Timepoint
Recovery and 24 hour after surgery
Method of measurement
mg

Secondary outcomes

1

Description
Agitation
Timepoint
5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after ward admission
Method of measurement
Richmond Agitation Sedation Scale

Intervention groups

1

Description
1th Intervention:2 cc of bupivacaine 0.5%, 6 ml of distilled water
Category
Treatment - Drugs

2

Description
2th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%
Category
Treatment - Drugs

3

Description
3th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%
Category
Treatment - Drugs

4

Description
4th Intervention: ketamine 5%, 1mg/kg
Category
Treatment - Drugs

5

Description
Control: 2 cc of normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Ali Valizadeh
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran 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
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
www.tums.ir

Person responsible for updating data

Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Ali Valizadeh
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6312 0000
Email
alivalizadeh@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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