Hysteroscopy has become a widely accepted technique in the diagnosis and treatment of various gynecological conditions. Various types of anesthesia have been reported for diagnostic and operative hysteroscopic procedures. There are no controlled studies comparing different techniques of anesthesia. The aim of this study is to compare spinal versus general anesthesia regarding to per-operative outcomes in patients undergoing operative hysteroscopy. In a prospective comparative study, 76 ASA class I or II women aged 20-70 years are randomly assigned to undergo operative hysteroscopy with either spinal or total intravenous anesthesia. Inclusion criteria are patient aged 20-70 years; ASA class I or II; operative hysteroscopy; immediately after menstruation and exclusion criteria are contraindication for neuraxial block; allergy to local anesthetics; systemic disorders( cardiac, respiratory, hepatic, ...); psychosomatic disease; diagnostic hysteroscopy; large fibroid ( uterine size> 12 w),and uterine prolapses. Outcomes are being the mean amount of irrigation fluid absorbed, postoperative serum sodium levels, incidence of hyponatremia, and level of patient's. satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402187013N11
Registration date:2014-06-06, 1393/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-06, 1393/03/16
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-24, 1393/03/03
Expected recruitment end date
2015-01-22, 1393/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Spinal Anesthesia with Total Intravenous Anesthesia during Operative Hysteroscopy
Public title
Comparison of ٍEffectiveness of Spinal Anesthesia with General Anesthesia during Operative Hysteroscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patient aged 20-70 years; ASA class I or II; operative hysteroscopy; immediately after menstruation.
Exclusion criteria: contraindication for neuraxial block; allergy to local anesthetics; systemic disorders( cardiac, respiratory, hepatic, ...); psychosomatic disease; diagnostic hysteroscopy; large fibroid ( uterine size> 12 w),and uterine prolapses.
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
9321
Health conditions studied
1
Description of health condition studied
External causes of morbidity and mortality
ICD-10 code
Y85-Y89
ICD-10 code description
Sequelae of external causes of morbidity and mortality
Primary outcomes
1
Description
َmount of irrigation fluid absorbed
Timepoint
End of operation
Method of measurement
ml
2
Description
patient's satisfaction scoring
Timepoint
During 24h after operation
Method of measurement
A four-point scale( weak, moderate, good, and excelent)
Secondary outcomes
1
Description
Serum sodium levels
Timepoint
End of operation
Method of measurement
mEq/l
Intervention groups
1
Description
In the control group (n=38) patients undergoing total intravenous anesthesia with midazolam, remifentanil and propofol. Maintenance of anesthesia is being with infusion of remifentanyl and propofl during procedure.
Category
Treatment - Drugs
2
Description
In the study group (n=38) patients undergoing spinal anesthesia at patient in sitting position, l3-4 or l4-5 interspinous space with 25-G quinke needle, and lidocaine 50 mg and fentanyl 15 µg medications.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Alzahra Hospital, South ArteshStreet, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medicalُ Sciences
Full name of responsible person
Dr. Rashidi
Street address
Vice chancellor for research, Daneshgah Street, Tabriz
City
Tabriz
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, Tabriz University of Medicalُ 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, Sought Artesh Street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Alzahra Hospital, south Artesh ُStreet,Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)