Anesthesia Clinical Trial
— IVFOfficial 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
Verified date | August 2019 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | June 21, 2019 |
Est. primary completion date | May 21, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sedat Akbas | Malatya | Türkiye-Türkçe |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Turkey,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Heart rate | Heart rate is measured as beats/minute on the anesthesia monitor | From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) | |
Secondary | Mean arterial pressure | Mean arterial pressure is measured as mmHg on the anesthesia monitor | From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) | |
Secondary | Peripheral oxygen saturation | Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor | From beginning of Anesthesia induction to the end of anesthesia (during perioperative period) |
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