Comparison of Zolpidem and melatonin in postoperative pain control in intervertebral disc herniation surgery under general anesthesia
Design
The study will be double blind and clinical trial.60 patients will be randomly divide into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with herniated lumbar intervertebral disc surgery in Valiasr hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for intervertebral disc herniation surgery, 17 to 65 years, absence of coagulation disorders, no history of drug use in the last 48 hours, psychedelics and alcohol, lack of platelet count less than 150 thousand, no family history of thromboembolism, L2 - L5 surgery and laminectomy
Exclusion criteria: Reluctance to participate in the study
Intervention groups
Intervention group 1: We will receive 6 milligram of sublingual melatonin (Webber Natural Co) dissolved in water (final volume 5 ml) 90 minutes before surgery.
Intervention group 2:We will receive 10 milligram of zolpidem in the form of tablets dissolved in water (manufactured by Hakim Pharmaceutical Company - Iran) 90 minutes before surgery.
Main outcome variables
Pain ,mean of narcotics consumption in 24 hours after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N161
Registration date:2021-06-22, 1400/04/01
Registration timing:registered_while_recruiting
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Zolpidem and melatonin in postoperative pain control in intervertebral disc herniation surgery under general anesthesia
Public title
Comparison of Zolpidem and melatonin in postoperative pain control in intervertebral disc herniation surgery under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for intervertebral disc herniation surgery
17 to 65 years
Both gender
Absence of coagulation disorders
Absence of liver disease and renal disease and heart disease
No history of drug use in the last 48 hours
No addiction to drugs, psychedelics and alcohol
Lack of sensitivity to the studied drugs
Lack of platelet count less than 150 thousand
No family history of thromboembolism
Absence of severe hemodynamic instability
L2 - L5 surgery and laminectomy
Exclusion criteria:
Reluctance to participate in the study
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B . In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group.The syringes are covered with foil.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.ARAKMU.REC.1400.006
Health conditions studied
1
Description of health condition studied
Herniated lumbar intervertebral disc
ICD-10 code
M51.26
ICD-10 code description
Other intervertebral disc displacement, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
During recovery and at 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual analog scale of pain
2
Description
Mean of narcotics consumption
Timepoint
24 hours after surgery
Method of measurement
Patient file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We will prescribe 6 milligram of sublingual melatonin (Webber Natural Co) dissolved in water (final volume 5 ml) 90 minutes before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2:We will prescribe 10 milligram of zolpidem in the form of tablets dissolved in water (manufactured by Hakim Pharmaceutical Company - Iran) 90 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?