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Comparative evaluation of effect of General anesthesia, Spinal anesthesia and Paracervical block on pain, nausea, vomiting and analgesic requirements in diagnostic Hysteroscopy.

Protocol summary

Study aim
Comparison of effect of General anesthesia, Spinal anesthesia and Paracervical block on pain, nausea, vomiting and analgesic requirements in diagnostic Hysteroscopy.
Design
This phase 2 clinical trial with parallel groups and without control group will be performed on 66 patients aged 18 to 45 years who are candidates for diagnostic hysteroscopy.
Settings and conduct
In general anesthesia group, 0.02mg/kg midazolam,1ug/kg Fentanyl and 2mg/kg of propofol are injected intravenously and the suitable LMA is placed.In spinal anesthesia group, after spinal anesthesia, 0.02 mg/kg of midazolam and 1ug/kg fentanyl are ingected intravenously for sedation. In paracervical group, first 0.02mg/kg midazolam and 1ug/kg fentanyl Injected intravenously and after 3-5 minutes,10 ml lidocaine 2% will inject by a spinal needle no.25 at 3, 9, 5 and 7 hours in cervico vaginal junction.The patient is then subjected to hysteroscopy with a rigid hysteroscope and vital signs, nausea, analgesic consumption and patient satisfaction at different times are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18 to 45 years; ASA class1&2; Candidate for hysteroscopic surgery; Do not use analgesics for 24 hours before surgery; Absence of contraindications to spinal anesthesia and general anesthesia. Exclusion criteria: History of allergies to local anesthetics and propofol; Electrolyte disturbances; History of previous hysteroscopic surgery; History of nausea and vomiting following previous anesthesia or history of motion sickness; Lack of patient cooperation after initial interventions and coagulation disorders.
Intervention groups
In this study, patients in three groups of general anesthesia, spinal anesthesia and paracervical block are evaluated for vital signs, nausea, analgesic consumption and satisfaction.
Main outcome variables
The VAS of pain and analgesic requirment in recovery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N26
Registration date: 2021-11-07, 1400/08/16
Registration timing: prospective

Last update: 2021-11-07, 1400/08/16
Update count: 0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-05, 1400/09/14
Expected recruitment end date
2022-03-05, 1400/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effect of General anesthesia, Spinal anesthesia and Paracervical block on pain, nausea, vomiting and analgesic requirements in diagnostic Hysteroscopy.
Public title
Comparison of three anesthesia methods in hysteroscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 45 years ASA class1&2 Candidate for diagnostic hysteroscopic surgery Satisfaction to participate in the study Do not use analgesics for 24 hours before surgery Absence of contraindications to spinal anesthesia and general anesthesia
Exclusion criteria:
History of allergies to local anesthetics and propofol Cardiac,respiratory,renal and liver diseases Candidate patients for myomectomy or polypectomy with resectoscope Electrolyte disturbances (sodium, potassium and calcium Uterine prolapse History of previous cervical or hysteroscopic surgery History of nausea and vomiting following previous anesthesia or history of motion sickness Lack of patient cooperation after initial interventions Coagulation disorders
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Not 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
Ethics committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.REC.1399.875

Health conditions studied

1

Description of health condition studied
Hysteroscopic surgery under general anesthesia, spinal anesthesia or para cervical block
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post operative pain
Timepoint
After surgery in recovery
Method of measurement
Using visual analog scale (VAS)

2

Description
Analgesic requirement
Timepoint
After surgery in recovery
Method of measurement
Based on the amount of analgesia requested by the patient

Secondary outcomes

1

Description
Systolic and Diastolic Blood Pressure
Timepoint
Before and after general or regional anesthesia, insertion of Spacolom and Tenacolom, dilation of cervix,insertion of hysteroscope, biopsy and extraction of hysteroscope
Method of measurement
Non-invasive automatic barometric device

2

Description
Nausea & vomiting
Timepoint
After surgery in recovery
Method of measurement
Observation

3

Description
Heart Rate
Timepoint
Before and after general or regional anesthesia, insertion of Spacolom and Tenacolom, dilation of cervix,insertion of hysteroscope, biopsy and extraction of hysteroscope
Method of measurement
Pulseoximetry

4

Description
Shivering
Timepoint
After surgery in recovery
Method of measurement
Observation

5

Description
Satisfaction rate
Timepoint
Before discharge from recovery
Method of measurement
Asking the patient

Intervention groups

1

Description
Intervention group1: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in general anesthesia group, 0.02mg/kg midazolam, 1ug ​/kg Fentanyl and 2mg/kg of propofol are injected intravenously and then the suitable LMA is placed (proportional to the patient's weight) and is used to maintain anesthesia from 1.2% isoflurane and 50%N2o.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured.
Category
Treatment - Drugs

2

Description
Intervention group 2: In all patients after entering the operating room, using a 18 intravenous lines, after receiving serum 5 ml/kg of serum Ringer, in spinal anesthesia group, the patient is placed in a sitting position and after determining the subarachnoid space in the L3-L4 or L4-L5 space, 2.5 mg of 0.5% bupivacaine is injected.Then, sensory level is examined by pinprick and in an anesthetic level of T10, the surgical procedure started and 0.02 mg/kg of midazolam and 1ug/kg fentanyl are used for sedation.The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured.
Category
Treatment - Drugs

3

Description
Intervention group 3: In all patients after entering the operating room, using a 18 intravenous lines, after receiving 5 ml/kg of serum Ringer, in paracervical group, first 0.02mg/kg midazolam and 1ug/kg fentanyl Injected intravenously and after 3-5 minutes, 10 ml lidocaine 2% will inject by a spinal needle no.25 at 3, 9, 5 and 7 hours in cervico vaginal junction, and after 5 minutes, the patient is evaluated for adequate anesthesia and surgery will begin. The patient is then subjected to hysteroscopy with a rigid hysteroscope (Storz Hysteroscope No. 7, Germany), and the uterine cavity is dilated using Glycine solution1.5% and vital signs(Saadat,162 model, non invasive monitoring, Iran), nausea, pain (VAS), analgesic consumption and patient satisfaction(%) at different times are measured.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieth Hospial, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.co

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital,Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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