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Comparative study of the prophylactic effect of neostigmine and atropin combination on the occurrence of post-dural puncture headache in patients undergoing spinal anesthesia with control group

Protocol summary

Study aim
Determining the prophylactic effect of neostigmine and atropine combination on the occurrence of post-dural puncture headache in patients undergoing spinal anesthesia with a control group
Design
A randomized double-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 100 patients will be included as candidates for lower extremity and lower abdomen surgery and will be randomly divided into two groups. Neostigmine and atropine will be used in one group and normal saline in the other. Then the severity of patients' headaches is evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patient consent to participate in the study, American Society of Anesthesiologists classification of I and II, and surgery duration less than 2 hours. Exclusion criteria include taking anticoagulants, presence of nerve damage in limbs and spine, coagulation diseases, history of spinal surgery, spinal canal stenosis and MS, conduction disorders of the heart, history of migraine headaches, addiction to drugs, and a history of malignancy.
Intervention groups
In this study, all patients will undergo spinal block. After performing spinal block and confirming its accuracy, patients in the intervention group will be prescribed a combination of 400 g of neostigmine and 200 g of atropine and in the control group normal saline. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously.
Main outcome variables
Severity of headache, duration of headache

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N11
Registration date: 2020-11-09, 1399/08/19
Registration timing: prospective

Last update: 2020-11-09, 1399/08/19
Update count: 0
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the prophylactic effect of neostigmine and atropin combination on the occurrence of post-dural puncture headache in patients undergoing spinal anesthesia with control group
Public title
The prophylactic effect of neostigmine and atropin combination on the occurrence of post-dural puncture headache in patients undergoing spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to participate in the study American Anesthesiologists Association Classification I and II Duration of surgery less than 2 hours
Exclusion criteria:
Taking anticoagulants Existence of a nerve lesion in the limb/spine Coagulation diseases History of spinal surgery, spinal canal stenosis Conductive disorders of the heart History of migraine headaches Opioid addiction History of malignancy
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the drug combination of "neostigmine and atropine" and normal saline were prepared by the operating room nurse in the same volume and marked with labels A and B. It is then given daily to the researcher and will be administered accidentally for patients. Therefore, the patient and the researcher will not have any information about the two prescribed drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.MUI.MED.REC.1399.258

Health conditions studied

1

Description of health condition studied
Lower limb surgery
ICD-10 code
S89.92XA
ICD-10 code description
Unspecified injury of left lower leg, initial encounter

Primary outcomes

1

Description
Pain severity
Timepoint
From first day to seven days after surgery
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Duration of headache
Timepoint
From first day to seven days after surgery
Method of measurement
Counting the number of days suffering from headache

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients in this group will be subjected to the spinal block as usual. After confirmation of anesthesia, normal saline is administered intravenously per 10 kg of patient weight.
Category
Placebo

2

Description
Intervention group: Patients in this group will be subjected to the spinal block as usual. After confirmation of the anesthesia, a combination of 400 g of neostigmine and 200 g of pre-prepared atropine is administered intravenously for every 10 kg of patient weight.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mohammad Golparvar
Street address
Anesthesiology Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
z.ahmadzade@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
z.ahmadzade@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
z.ahmadzade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Ahmadzadeh
Position
Non-faculty specialist physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, faculty of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
z.ahmadzade@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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