Protocol summary

Summary
This study is going to evaluate the effect of intravenous midazolam on duration of sensory and motor block in spinal anesthesia. This study will be a double blind clinical trial on 36 candidates of elective lower abdomen and lower limb surgeries under spinal anesthesia in Alzahra Medical Center (Isfahan, Iran). Patients who meet the inclusion criteria such as age between (20-60) years old, American Society of Anesthesiologists classification (ASA) of I and II, no contraindication for the consumption of midazolam or benzodiazepine and no history of alcohol or other substance abuse will be enrolled in this study. Patients will be selected by simple sampling and randomized into two groups of 18 patients each by randomization software. All patients will receive 10 cc/kg Ringer’s lactate serum before spinal anesthesia. Spinal anesthesia will be performed by 2 ml of lidocaine 5% in sitting position at L3-L4 or L4-L5 intersegments. The subjects in the first group will receive 0.03 mg/kg midazolam and 1 μg/kg fentanyl intravenously with the time interval of five minutes. Patients in the second group (control group) will receive normal saline (2cc) plus 1 μg/kg fentanyl intravenously with the same time interval. An anesthesiologist, who will not be involved in the study, prepares the study solutions. Therefore, patients and investigators will be blinded to the patient group assignment. The highest dermatome level of sensory blockade, time to achieve maximum motor and sensory block level, duration of sensory and motor block and any side effect (regarding hypotension, nausea, vomiting) will be measured by an investigator. Moreover, heart rate, systolic and diastolic blood pressures, arterial oxygen saturation and sedation score will be recorded at five minutes before surgery and later every five minutes during the surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090716415N5
Registration date: 2014-09-29, 1393/07/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Isfahan University of medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluating effect of intravenous midazolam on duration of spinal anesthesia in comparison to control group
Public title
Evaluating effect of intravenous midazolam on duration of spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
20 to 60 years old; class American Society of Anesthesiologists (ASA) I or II; no contraindication for midazolam; no benzodiazepine medication before surgery; no history of alcohol or other substance abuse
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Deputy of Research and Technology of Isfahan University of Medical Sciences
Street address
Deputy of Research and Technology, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
2662/8/د

Health conditions studied

1

Description of health condition studied
Spinal Anesthesia
ICD-10 code
E938.7
ICD-10 code description
Spinal anesthetics causing adverse effects in therapeutic use

Primary outcomes

1

Description
Duration of sensory and motor block
Timepoint
Every 2-5 minutes
Method of measurement
Pinprick testing

Secondary outcomes

1

Description
Sedation Score
Timepoint
Every 5 minutes
Method of measurement
Ramsy Sedation Score

Intervention groups

1

Description
Intravenous Midazolam injection
Category
Treatment - Drugs

2

Description
Intravenous normal saline (placebo)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Golparvar M. MD
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulevard, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and technology of Isfahan University of Medical Sciences
Full name of responsible person
Dr Alimohammad Sabzeghabaei
Street address
Research manager office, Deputy of research and technology, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and technology of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar M MD
Position
Associated professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulvard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associated Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associated Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
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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