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Effect of time pause between the administration of midazolam and ketamine on post- anesthetic delirium of ketamine in minor gynecologic surgeries

Protocol summary

Summary
The aim of this study was to evaluate the latency interval effect of midazolam and ketamine's post-anesthetic delirium in minor gynecologic surgeries. Informed consent will be obtained after patients enter operating room. In this randomized double blind clinical trial 100 women undergoing minor gynecological surgeries are assigned to 4 groups according to the time intervals of 0, 2.5, 5, 7.5 minutes between midazolam (0.05 mg/kg) and ketamine (1.5 mg/kg) doses administrated. Inclusion criterion: Women aged 16-50 with minor gynecologic surgeries which last less than 20 minutes, elective surgery, sent to recovery room after surgery, class ASA I & II. Exclusion criterion: History of sensitivity to midazolam or ketamine, history of psychiatric and neurological illnesses, history of heart disease and/or kidney failure under treatment, addiction to drugs or psychotropic substances, body mass index of over 30 or under 18. The patients' degree of tranquility, speech, and delirium which are considered as components of delirium are evaluated after complete awakening and obeying commands till discharge from the recovery room. The researcher who will be recording the intensity of delirium in recovery room is blinded to the time intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010518091N7
Registration date: 2016-02-26, 1394/12/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-26, 1394/12/07
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental resources of Shariati Hospital of Bandar Abbas, Hormozgan University of Medical Sciences
Expected recruitment start date
2016-01-10, 1394/10/20
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of time pause between the administration of midazolam and ketamine on post- anesthetic delirium of ketamine in minor gynecologic surgeries
Public title
Does applying different time intervals between administering midazolam and ketamine affect the the delirium effect of ketamine in minor gynecologic surgeries after the patient has awakened from anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: women aged between 16-56 years old with minor gynecologic surgeries which last less than 20 minutes; elective surgery; sent to recovery after surgery; class ASA I & II. Exclusion criterion: history of sensitivity to midazolam or ketamine; history of psychiatric and neurological illnesses; history of heart disease and/or kidney failure under treatment; addiction to drugs or psychotropic substances; body mass index of over 30 or under 18.
Age
From 18 years old to 50 years old
Gender
Female
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
Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital,
City
Bandar Abbas
Postal code
7919915519
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
3-HEC-93-8-20

Health conditions studied

1

Description of health condition studied
Delirium after ketamine administration in minor gynecological operations
ICD-10 code
F05.8
ICD-10 code description
Postoperative delirium

Primary outcomes

1

Description
Rest Score
Timepoint
After being able to obey to commands in recovery room
Method of measurement
screening scale (1 = very calm, 2 = calm, 3 = restless, 4 = very restless, 5 = extremely restless)

2

Description
Talk Score
Timepoint
After being able to obey to commands in recovery room
Method of measurement
(1 = very quiet, 2 = quiet, 3 = talked a little, 4 = talked a lot, 5 = called or cried out)

3

Description
Delirium Score
Timepoint
After being able to obey to commands in recovery room
Method of measurement
(1 = definitely not, 2 = no, 3 = perhaps, 4 = yes, 5 = definitely yes)

Secondary outcomes

empty

Intervention groups

1

Description
First group (zero minute): administering intravenous midazolam 0.05 mg/kg and immediately after this administering intravenous ketamine 1.5 mg/kg
Category
Treatment - Drugs

2

Description
Second group (two and half minutes): administering intravenous midazolam 0.05 mg/kg and after 2.5 minutes administering intravenous ketamine 1.5 mg/kg
Category
Treatment - Drugs

3

Description
Third group (five minutes): administering intravenous midazolam 0.05 mg/kg and after 5 minutes administering intravenous ketamine 1.5 mg/kg
Category
Treatment - Drugs

4

Description
Forth group (seven and half minutes): administering intravenous midazolam 0.05 mg/kg and after 7.5 minutes administering intravenous ketamine 1.5 mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital of Bandar Abbas
Full name of responsible person
Majid Vatankhah
Street address
Shahid Naseri blvd., Kansolgari, Shariati Hospital
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Deputy of Research Center, Shahid Mohammadi Hospital, Joomhoori Islami blvd.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Anesthesiology and Intensive care sub-specialist
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.,
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
Email
hormozgan91@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.,
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
Email
hjarineshin@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S
Full name of responsible person
Fereydoon Fekrat
Position
Specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.,
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
fereydoonfekrat@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/

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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