Objective: Hemodynamic changes are a major cause of concern in laparoscopic surgery. Design and Participants:In this study 60 patients, intraoperative hemodynamic effect of satellite ganglion block and complications after laparoscopic surgery for women is investigated.Intervention:Fifteen minutes before induction of anesthesia and involves an ultrasound exam with 10 mL of lidocaine 1% in the intervention group satellite ganglion block and control group are also listed conditions will receive 10 cc distilled water as placebo.Induction of anesthesia, care and monitoring of patients perform by second doctor who is blinded to groups.
Main outcome:All hemodynamic parameters such as blood pressure, heart rate, especially in periods after intubation, during and after blowing a CO2 gas switching positions (Trendelenburg) is recorded.After the surgery, the postoperative pain using the NRS criteria will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012510599N14
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Stellate Ganglion Block on hemodynamic intraoperative and postoperative complications of Laparoscopic Surgery in women
Public title
Control Blood Pressure and Heart Rate during Laparoscopic Surgery with Stellate Ganglion Block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women 40-20 years; Candidate for elective laparoscopic surgery; ASA I-II class
Exclusion criteria: ASA III class or above; Emergency Surgery; chronic use of pain medication, alcohol or drug addiction; BMI over 30 ; ischemic heart disease; hypertension; renal dysfunction; Diabetes; Anti-coagulant therapy
Age
From 19 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients randomized method with block randomization divided in two groups of intervention and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemat exp Way, Tehran, Iran
City
tehran
Postal code
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.95-03-218-29652
Health conditions studied
1
Description of health condition studied
Relationship of Stellate Ganglion Blood with Hemodynamics During Operation and Post-Operative Complications in women
ICD-10 code
Z01.3
ICD-10 code description
Examination Of Blood Pressure
Primary outcomes
1
Description
BloodPressure
Timepoint
In the beginning, after induction, after intubation, after insufilation gas, while repositioning, the net outflow of gas, in recovery
Method of measurement
Automatic non-invasive blood pressure measurement
2
Description
Heart Reate
Timepoint
At first- after induction, after intubation, after insuffilation Tzyq gas, while repositioning, the net outflow of gas, in recovery
Method of measurement
Continuous monitoring heart rate
3
Description
post operative pain
Timepoint
The beginning of the recovery, 30 minutes later, 24 hours after surgery.
Method of measurement
Numerical pain scale (NRS is a standard measure)
Secondary outcomes
1
Description
Conjectival and nasal congestion
Timepoint
Immediately after injection
Method of measurement
visual
Intervention groups
1
Description
Group Intervention: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 mL of 1% lidocaine blockade of the stellate ganglion block. we used the linear high frequency trancducer (6-13 mhz).
Category
Treatment - Drugs
2
Description
Control group: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 ml of distilled water are placed under the stellate ganglion block. we used the linear high frequency trancducer (6-13 mhz).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat - E Rasool Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
HAZRAT - E Rasool Hospital, Iran University of Medical Science, Niayesh, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical sciences
Full name of responsible person
Ali javad Mosavi
Street address
Iran University of Medical Sciences, Hemat, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Maryam Khodaverdi
Position
Anesthesiology Residents
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh St, Sattarkhan, Tehran
City
Tehran
Postal code
Phone
+98 21 6655 3921
Fax
Email
maryamkhodaverdi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pupak Rahim Zadeh
Position
Associated professor of Anesthesioligy-Pain FellowShip
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh St, Sattarkhan, Tehran
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
pupak_rah@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
maryamkhodaverdi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)