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A Comparison of Sedation/Analgesia & LMA on Anxiety Level and Patient Satisfaction in In-Vitro Fertilization (IVF)

Primary Purpose

Anesthesia, In-vitro Fertilization, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
State-Trait Anxiety Inventory
Quality of Recovery Score
Sedation/Analgesia
Laryngeal Mask Airway
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia focused on measuring Anesthesia management, In-vitro Fertilization, Sedation-Analgesia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) scores of I-II
  • Aged 18-55 years old

Exclusion Criteria:

  • American Society of Anesthesiology (ASA) scores of III-IV
  • Under 18 years of age
  • Over 55 years of age,
  • Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular events,
  • Patients with an allergy to anesthetic drugs
  • Pregnants
  • Patients who refused informed consent

Sites / Locations

  • Sedat Akbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sedation/Analgesia

Laryngeal Mask Airway

Arm Description

Patients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score

Patients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Quality of Recovery Score
Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.

Secondary Outcome Measures

Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Full Information

First Posted
January 4, 2019
Last Updated
August 16, 2019
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03814330
Brief Title
A Comparison of Sedation/Analgesia & LMA on Anxiety Level and Patient Satisfaction in In-Vitro Fertilization
Acronym
IVF
Official Title
A Comparison of Two Different Anesthetic Application (Sedation / Analgesia & LMA) on Anxiety Level and Patient Satisfaction in Patients With in Vitro Fertilization: Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization. The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation & laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
Detailed Description
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization. IVF requires the collection of mature oocytes from the ovaries of infertile patients. These oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos are transferred into the uterus of the patients. Ultrasonography-guided transvaginal aspiration makes oocyte intake less invasive compared to prior techniques and can be administered within 30 minutes. With the development of this method, trauma was minimalized and side effects were reduced. However, the possible effects of different anesthetics on oocytes are still being discussed. The potential side effects of different anesthesia applications have been observed not only in patients receiving oocytes, but also in embryo development and pregnancy success due to the quality of oocytes. The pain of patients is common after the puncture of the vaginal fornix. It is usually defined as deep menstrual pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should perform adequate pain relief to immobilize the patient to avoid the risk of perforating the vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the increased anxiety associated with social and psychological stress associated with IVF. Anxiety may develop before and after the procedure, especially in patients undergoing oocyte collection. The patient's anxiety is usually present before entering the operating room. The assessment, which was started to be developped by investigators, was aimed to measure state anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. Patient satisfaction depends on the patient's expectations and the benefits expected by the patients with the service they receive. Patient satisfaction is the result of meeting the wishes and expectations of the patients. An investigator has developed the Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200. No special training is required for the implementation of the survey. The fact that the patient can perform the survey on his own and can be done in a short time gives a significant advantage. The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation & laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, In-vitro Fertilization, Analgesia
Keywords
Anesthesia management, In-vitro Fertilization, Sedation-Analgesia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Clinical Trial
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedation/Analgesia
Arm Type
Placebo Comparator
Arm Description
Patients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score
Arm Title
Laryngeal Mask Airway
Arm Type
Active Comparator
Arm Description
Patients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score
Intervention Type
Diagnostic Test
Intervention Name(s)
State-Trait Anxiety Inventory
Intervention Description
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement
Intervention Type
Diagnostic Test
Intervention Name(s)
Quality of Recovery Score
Other Intervention Name(s)
Recovery Quality Score-40
Intervention Description
Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
Intervention Type
Other
Intervention Name(s)
Sedation/Analgesia
Intervention Description
Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Intervention Description
Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory
Description
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Time Frame
State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.
Title
State-Trait Anxiety Inventory
Description
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Time Frame
State-Trait Anxiety Inventory will be performed to the all patients 4 hours after the IVF procedure.
Title
Quality of Recovery Score
Description
Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
Time Frame
Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate is measured as beats/minute on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Title
Mean arterial pressure
Description
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Title
Peripheral oxygen saturation
Description
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients with In-Vitro Fertilization
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology (ASA) scores of I-II Aged 18-55 years old Exclusion Criteria: American Society of Anesthesiology (ASA) scores of III-IV Under 18 years of age Over 55 years of age, Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular events, Patients with an allergy to anesthetic drugs Pregnants Patients who refused informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedat Akbas, Asst. Prof.
Organizational Affiliation
Inonu University Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Sedat Akbas
City
Malatya
State/Province
Türkiye-Türkçe
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22420562
Citation
Piroli A, Marci R, Marinangeli F, Paladini A, Di Emidio G, Giovanni Artini P, Caserta D, Tatone C. Comparison of different anaesthetic methodologies for sedation during in vitro fertilization procedures: effects on patient physiology and oocyte competence. Gynecol Endocrinol. 2012 Oct;28(10):796-9. doi: 10.3109/09513590.2012.664193. Epub 2012 Mar 16.
Results Reference
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A Comparison of Sedation/Analgesia & LMA on Anxiety Level and Patient Satisfaction in In-Vitro Fertilization

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