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

NCT03814330 | Completed

• 1 other identifier: sedatakbas5
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; In-vitro Fertilization; Analgesia

Keywords

Anesthesia management; In-vitro Fertilization; Sedation-Analgesia

Outcome Measures

Primary Outcomes (3)

• 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 will be performed to the all patients 2 hours before the IVF procedure.

• 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 will be performed to the all patients 4 hours after the IVF procedure.

• 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.

  Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure

Secondary Outcomes (3)

• Heart rate

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

• Mean arterial pressure

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

• Peripheral oxygen saturation

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

Study Arms (2)

Sedation/Analgesia

PLACEBO COMPARATOR

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

Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Quality of Recovery Score; Other: Sedation/Analgesia

Laryngeal Mask Airway

ACTIVE COMPARATOR

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

Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Quality of Recovery Score; Device: Laryngeal Mask Airway

Interventions

State-Trait Anxiety Inventory DIAGNOSTIC_TEST

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

Laryngeal Mask Airway; Sedation/Analgesia

Quality of Recovery Score DIAGNOSTIC_TEST

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.

Also known as: Recovery Quality Score-40

Laryngeal Mask Airway; Sedation/Analgesia

Sedation/Analgesia OTHER

Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.

Sedation/Analgesia

Laryngeal Mask Airway DEVICE

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.

Laryngeal Mask Airway

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Patients with In-Vitro Fertilization
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Sedat Akbas

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 22420562 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia; Laryngeal Masks

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sedat Akbas, Asst. Prof.

  Inonu University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Sedat Akbas

Model Details: Prospective Randomized Clinical Trial

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 24, 2019
• Study Start: January 24, 2019
• Primary Completion: May 21, 2019
• Study Completion: June 21, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)