Effect of vitamin B12 infusion in prevention of nitrous oxide- induced homocysteine increase in patients undergoing general anesthesia for elective surgery
The aim of this randomized double-blind clinical trial is to evaluate Effect of vitamin B12 infusion in prevention of nitrous oxide-induced homocysteine increase. A total of 60 patients, meeting eligibility criteria, will be randomly allocated into three equal groups. Group A: before surgery 1mg Vitamin B12 with 100ml normal saline will be infused, during surgery % 60 nitrous oxide will be prescribed and after end of surgery100ml normal saline will be infused to patients.
Group B: before surgery 100ml normal saline will be infused, during surgery % 60 nitrous oxide will be prescribed and after end of surgery 1mg Vitamin B12 with 100 ml normal saline will be infused to patients. Group C: before and after end of surgery 100ml normal saline will be infused and during surgery % 60 nitrous oxide will be prescribed to patients. For all patients, a standard protocol for anesthesia will be applied uniformly. After anesthetia, in recovery room, a nurse (A Blinded observer) presence or absence of nausea and vomiting in patients will be recorded. Blood samples for measurement of serum B12 and homocysteine will be conducted in two stages: A- After transferring the patient to the operating room and tend to participate in the study. B- 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209226803N3
Registration date:2012-09-30, 1391/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-30, 1391/07/09
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin B12 infusion in prevention of nitrous oxide- induced homocysteine increase in patients undergoing general anesthesia for elective surgery
Public title
Effect of vitamin B12 infusion in prevention of nitrous oxide- induced homocysteine increase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; ASA class Ι-ΙΙ; Age between 18 and 45 years; Elective surgeries that operation time is estimated at more than 2 hours.
Exclusion criteria: Pregnancy; Emergency Surgery; Contraindications of nitrous oxide )such as Pneumothorax; Mechanical intestinal obstruction; Occlusion of the middle ear; Laparoscopic Surgery; Laser Surgery; Increased ICP); Intake of vitamin B12 and folate supplements before surgery; Contraindications of vitamin B12 and folate; Leber's disease; Patients with vitamin B12 or folate deficiency; megaloblastic anemia; Anesthesia in the past month; Smoking; Renal failure; hypothyroidism.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
866-48175
Approval date
2011-12-21, 1390/09/30
Ethics committee reference number
90-5
Health conditions studied
1
Description of health condition studied
Nitrous oxide in general anesthesia
ICD-10 code
Y14
ICD-10 code description
Poisoning by and exposure to other and unspecified drugs, medicaments and biological substances, undetermined intent
Primary outcomes
1
Description
plasma homocysteine
Timepoint
before intervention, 24h after intervention
Method of measurement
blood sampling
Secondary outcomes
1
Description
nausa and vomiting
Timepoint
after intervention in the end of surgery
Method of measurement
Questionnaire
2
Description
plasma vit B12
Timepoint
before intervention, 24h after intervention
Method of measurement
blood sampling
Intervention groups
1
Description
before surgery 1mg Vitamin B12 with 100ml normal saline will be infused, during surgery % 60 nitrous oxide will be prescribed and after end of surgery100ml normal saline will be infused to patients.
Category
Treatment - Drugs
2
Description
before surgery 100ml normal saline will be infused, during surgery % 60 nitrous oxide will be prescribed and after end of surgery 1mg Vitamin B12 with 100 ml normal saline will be infused to patients.
Category
Treatment - Drugs
3
Description
before and after end of surgery 100ml normal saline will be infused and during surgery % 60 nitrous oxide will be prescribed to patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amirmazandarani Ave.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospita, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 22 75038
Email
a.firouzian@mazums.ac.irab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesilogist, Assistant professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 22 75038
Email
a.firouzian@mazums.ac.irab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)