Aim: The effect of hypertension hysterectomy under general anesthesia during surgery on hypertensive patients developed postoperative pain. Design: a randomized, single-blind, single-center, phase II clinical trial. patients with treated chronic hypertension were divided into two groups with normal and upper range arterial blood pressure during surgery. Pain score will be recorded during the first 24 hours of operation. The main inclusion criteria included patients with a history of hypertension treatment. Exclusion criteria included patients with a history of analgesics (narcotic or non-narcotic) during the past week. Patients were divided into two groups with normal and upper range arterial blood pressure during surgery. The main outcome variables: Pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112916151N4
Registration date:2017-06-14, 1396/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypertension during hysterectomy surgery under general anesthesia on postoperative pain in hypertensive patients
Public title
Effect of intraoperative hypertension on pain after surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with a history of hypertension treatment. Exclusion criteria: patients with history of analgesics (narcotic or non-narcotic) during the past week; drug addiction; Chronic Pain; known cardiovascular; massive bleeding during surgery .
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2010-06-01, 1389/03/11
Ethics committee reference number
94/د/105/1387
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature
Primary outcomes
1
Description
Pain
Timepoint
During treatment
Method of measurement
Based on a visual scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intraoperative arterial blood pressure of patients is maintained in the high range.
Category
Treatment - Drugs
2
Description
Control group: Intraoperative arterial blood pressure of patients is maintained in the normal range .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr. Alireza Purnajafyan
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Purnajafyan
Position
Assistant Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
a-pournajafian@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Purnajafyan
Position
Assistant Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
a-pournajafian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz fateh bromand
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
00
Fax
Email
mfboroumand1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)