Aim: To compare opioid-sparing effect of pre-emtive low dose ketamine vs. loading and infusion dose of dexmedetomidine in opioid abusers.
Patients: one hundered opioid abusers (daily oral application of opium and/or methadone for the the last 6 weeks for non-medical purposes),undergoing laparascopic nephrectomy.
Method: After taking IRB and written informed consent, patients were randomly allocated into two groups. group K received 0.1 mg/kg bolus intravenous ketamine while in group D patients receive 0.5 mic/kg dexmedetomidine in 10 minutes before start of anesthesia and its infusion (0.1 mic/kg/h) continiued till the end of surgery.Both groups received same protocol of anesthesia with propofol and remifentanil and postoperatively PCA applied for 24 hours.
Measurement:Total amount of remifentanil (to maintain MAP within 20% range of its base) and postoperative opioid analgesia requirements (in the first 24 hours) were assessed as primary outcome. Discharge time from recovery, bradypnea, apnea, vomiting, itching, hemodynamic instability (changes of MAP or PR more than 30% lasting more than 5 minutes) were evaluated as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307203436N3
Registration date:2013-08-03, 1392/05/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Babak Gharaei
Name of organization / entity
Labbafijejad Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9029
Email address
b.gharaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of opioid sparing effect of low dose ketamine vs. dexmedetomidine in opioid abusers undergoing laparascopic nephrectomy
Public title
Dexmedetomidine vs ketamine to reduce analgesia requirement in opioid addicts
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:
1- ASA physical status I or II
2- No probability for difficult airway
3- No allergy to remifentanil, ketamine, propofol or dexmedetomidine
4- No alcohol, tranquilizer or intravenous drug abuse
5- No cognitive or memory disorder
6- No history for hypertension, Increased ICP, present pregnancy or psychiatry disorder
Exclusion:
1- surgery lasts more than 4 hours
2- Mean arterial pressure (MAP) change greater than 30 % lasting more than 5 minutes
3- Pulse rate change greater than 30% lasting more than 5 minutes
4- Application of drugs not mentioned in the protocol (however data is recorded)
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:
100
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Postal code
Approval date
2012-12-10, 1391/09/20
Ethics committee reference number
400-9491
Health conditions studied
1
Description of health condition studied
opioids abuse
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
post operative morphine requirement
Timepoint
(post intervention) 24 h postoperative
Method of measurement
mg
2
Description
Intra-operative remifentanil requirement
Timepoint
(during and post intervention) during surgery
Method of measurement
micrigram
Secondary outcomes
1
Description
Bradypnea (RR less than 8/min)
Timepoint
(after intervention) recovery
Method of measurement
pulse oximetry
2
Description
apnea (central apnea for more than 10 sec)
Timepoint
(after intervention) recovery
Method of measurement
Observation
3
Description
itching (post-operative complaint of patient)
Timepoint
(after intervention) recovery and 24 h post-operatively
Method of measurement
Observation
4
Description
Recovery discharge time
Timepoint
(after intervention) recovery
Method of measurement
minutes from arrival to discharge
5
Description
Hemodynamic instability
Timepoint
(during and after intervention) under anesthesia
Method of measurement
blood pressure and heart rate every 5 minutes (recording)
Intervention groups
1
Description
Intervention:
Pre-emptive bolus intravenous ketamine (0.1 mg/kg) with normal saline infusion (similar to other group for blinding)
Category
Prevention
2
Description
Intervention:
Intravenous dexmedetomidine (0.5 mic/kg in 10 min as loading then 0.1 mic/kg/h till the end of surgery) one bolus normal saline for blinding
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Babak Gharaei
Street address
9th Boostan, Pasdaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti University of Medical Science
Full name of responsible person
Homayoun Aghamohammadi
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti 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
Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti University of Medical Science
Full name of responsible person
Babak Gharaei
Position
Assistant professor
Other areas of specialty/work
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 2360 2175
Fax
Email
babakgharaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti University of Medical Science
Full name of responsible person
Babak Gharaei
Position
Assistan Professor
Other areas of specialty/work
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 2360 2175
Fax
Email
babakgharaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Research Center, Labbafinejad hospital, Shahid Beheshti University of Medical Science