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
Phase: NA
Conditions: Anesthesia, In-vitro Fertilization, Analgesia
Sponsor: Inonu University

18.04.2018 
Title Page 
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 
*Sedat Akbas, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Faculty of Medicine, Malatya, Turkey. 
Ahmet Selim Ozkan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu 
University Faculty of Medicine, Malatya, Turkey. 
Abdullah Karaer, Prof. Dr. Division of Reproductive Endocrinology, Department of 
Obstetrics and Gynecology, Inonu University Faculty of Medicine, Malatya, Turkey. 
Gorkem Tuncay. Asst Prof. Division of Reproductive Endocrinology, Department of 
Obstetrics and Gynecology, Inonu University Faculty of Medicine, Malatya, Turkey. 
 
Address all correspondence to: 
Sedat Akbas, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Mail: drsedatakbas@gmail.com 
Phone Number: +905058263912  
Fax Number: +904223410728 
 
A short title: Anesthesia Management of in Vitro Fertilization 
Conflict of Interest:  
The authors declare that they have no conflict of interest. 
Funding Information:  
None 

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Study Protocol 
This trial was approved by the Local Ethic Committee of Inonu University (Protocol no: 
2018/56, Approval Date: 18.04.2018). We conducted a prospective, randomized controlled 
clinical trial with 140 female patients undergoing in vitro fertilization (IVF) at an university 
hospital.  
Patients with American Society of Anesthesiology (ASA) scores of I-II and who were aged 18–
55 years old will be included in our study. Patients will be interviewed before surgery to obtain 
informed consent. Patients with ASA 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 pregnant were excluded. Patients who refused 
informed consent will be also excluded.  
All of the patients one day before surgery; hemoglobin, hematocrit, prothrombin time, active 
partial thromboplastin time, aspartate aminotransferase, alanine aminotransferase will be 
evaluated. Electrocardiography and preoperative anesthetic evaluations will be performed. The 
patients who will agree to participate in the study will fill the demographic data form and STAI 
TX-1 (State Anxiety Scale Scale) form 2 hours before the procedure. Standard monitoring 
procedures will be used, including heart rate (HR), noninvasive blood pressure (NIBP), 
electrocardiogram (ECG), and peripheral oxygen saturation (SpO2).  
Age, gender, height, weight, body mass index (BMI), ASA scores, laboratory values, duration 
of anesthesia, duration of the procedure, concomitant diseases, preoperative symptoms, 
anesthetic drugs and doses used, causes and duration of infertility, anesthesia and complications 
of surgery will be recorded. HR (heart rate), SAB (systolic arterial pressure), DAB (diastolic 
arterial pressure), MAP (mean arterial pressure), DSS (respiratory rate), peripheral oxygen 
saturation (SpO2) values will be recorded at preoperative, peroperative and postoperative 

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periods. Patients, who will not experience complications during the procedure, will be 
transferred to the post-anesthesia care unit (PACU) after the procedure. VAS score (Visuel 
Analog Scale) and RAMSEY sedation score will be recorded for the patients followed up in the 
PACU. Patients will be transferred to the service when they achieved a score of 9 or higher on 
the Modified Aldrete score (range 0 –12; scores of 9 and above indicate that the patient can be 
discharged from the PACU). In all patients, postoperative analgesia will be achieved IV 
analgesic medication using appropriate doses of paracetamol (1 gr, IV). Patients will complete 
the QoR-40 questionnaire, which is a Patient Satisfaction Survey, 24 hours after discharge. 
Randomization was performed with the MedCalc for Windows (medcalc.com.tr.), version 16 
statistical software. 140 patients will be randomly allocated to two study groups: Sedation 
Analgesia group (Group S, n = 70) and Maryngeal Mask Airway, LMA (Group L, n = 70). 
Midazolam 0.05 - 0.1 mg.kg-1 IV will be performed for premedication before the procedure in 
both groups. No inhalation anesthetics will be used in groups. In both groups, Anesthesia will 
be induced and maintained with propofol 1-2 mg.kg-1 IV, remifentanil 0.05 - 0.1 mcg kg-1 IV 
or fentanyl 1-2 mcg kg-1 IV.  
 
 
 
 
 
 
 

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Statistical Analysis: 
Data will be analyzed using the Statistical Package for the Social Sciences program (SPSS 22.0, 
IBM). As some pre and anesthetic characteristics of patients will be distributed abnormally 
nonparametric statistics will be used. Quantitative data are presented as mean or standard 
deviation and categorical data are shown as numbers or percentages. Continuous variables will 
be compared between the groups using Mann-Whitney U-test. Categorical variables will be 
summarized using frequencies and percentages (%) and compared between the groups using 
Chi-Squared Test. The results will be evaluated at a 95% confidence interval at a significance 
level of p<0.05.