Although pre operative anxiety in a patient undergoing surgery under anaesthesia is a well known entity but it is not assessed routinely. Mild anxiety may not cause harm to the patient while severe anxiety can be extremely harmful and have a serious impact on patient’s mental and physical health. Patient’s pre operative anxiety has a substantial impact on recovery from anaesthesia as it affects different aspects of perioperative situations, such as the preoperative visit, induction and maintenance of anaesthesia, postoperative demands and physical recovery.
Patients with primary infertility are already anxious due to social pressures and inability to conceive normally. Their anxiety levels are aggravated when they undergo surgical procedures like diagnostic or operative hysterolaparoscopy under anaesthesia both because of the fear of procedure and anaesthesia and also, because of the need for information regarding the procedure and results of the diagnostic procedure thereafter. We hypothesize that this exaggerated anxiety level can significantly affect their recovery from anaesthesia and incidence of post operative side effects like shivering, nausea and vomiting and higher pain scores. To study the increased anxiety level in patients with primary infertility as compared to age matched controls undergoing other surgeries under general anaesthesia, we planned this as case control study.
Many scores have been described for assessment of anxiety like Spielberger’s state-trait anxiety inventory, Beck’s anxiety inventory. However, the components of these scores are indistinguishable from those to assess depression. To overcome the contamination of anxiety score with element of depression, Amsterdam pre operative anxiety and information scale (APAIS) was suggested to assess patient’s pre operative anxiety and need for information. APAIS is valid, reliable and easy to apply scoring system to assess a patient’s anxiety level as well as the need for information. It has two components, anxiety scale which assesses patient’s anxiety and need to information scale which assesses patient’s need for information regarding the procedure and anaesthesia. The simplicity of APAIS allows the patients to easily and quickly complete the score.
We plan to conduct an observational, case control study to assess the effect of anxiety in patients with primary infertility, undergoing hysterolaparoscopy under general anaesthesia, using APAIS, on their post operative recovery and pain score.
Aim
1. To study the effect of pre operative anxiety in patients with primary infertility undergoing hysterolaparoscopy under general anaesthesia on recovery from anaesthsia and post operative pain scores.
2. To study same parameters in age matched controls undergoing another surgery under general anaesthesia, as case control group.
Methodology
Subjects
After approval from institutions Ethics committee, 60 patients with primary infertility, between 20-40 years of age, undergoing hysterolaparoscopy under general anaesthesia will be assessed for pre operative anxiety based on Amsterdam pre operative anxiety and need for information score. The control group will include thirty patients of same age group undergoing another surgery under general anaesthesia. A written informed consent will be taken from the patients for their willingness to participate in study and they will be informed about the anonymous character of study. Patient refusing to participate, patients with history of psychiatric disorder, seizure, ASA physical status 3 or more and patients undergoing neurosurgical procedure will be excluded from the study.
Study Design
This will be an observational, case control study in which one anaesthesiologist will independently record each patient’s APAIS and other demographic data and a second anaesthesiologist will independently record the intraoperative and postoperative data. The data collected will not be revealed to either of anaesthesiologists till the end of the study.
Scores
Patient’s anxiety level and need for information regarding the surgical procedure and anaesthesia will be assessed on the basis of Amsterdam pre operative anxiety and information score (APAIS). Patients with diagnosis of primary infertility will then be stratified into low or high anxiety groups as per their APAIS score. The anxiety scale consists of four items each of which could be scored from 1 to 5 on Likert scale (1,never; 2, low; 3, moderate; 4, strong; 5, extreme). The score of the anxiety scale is the sum of these four questions, with a scoring range from 4 to 20. A cut off value score of 13 on anxiety scale will be used to stratify the patients with primary infertilty in two groups, high and low anxiety.
Post operative recovery will be assessed using modified Aldrete Score which will be recorded every 5 minutes from the time patient reaches recovery room till the value of score is 9. A score of 9 or more will confirm recovery from anaesthesia. Patients will also be assessed for postoperative nausea and vomiting, pain score according to numeric rating scale from 0 to 10 with value of 0 representing no pain and 10 representing worst imaginable pain. Presence of shivering and/or agitation will also be recorded. Time to acceptance of oral intake and time to meet the discharge criteria will also be recorded.
Clinical observations and procedures
Pre operatively, all patients will receive tablet alprazolam 0.25mg on the night before and on the morning of surgery. In pre operative room, all patients will fill APAIS (Appendix I), made available to them in language they best understand that is, Hindi or English. After recording demographic data, all patients will be anaesthetized using standard practice. Continuous ECG, non invasive blood pressure, end tidal carbon dioxide levels and pulse oximetry will be recorded throughout the procedure. All patients will receive injection fentanyl (1-2mcg/kg), induction with propofol (1-2mg/Kg) and will be intubated using neuromuscular blockade with injection atracurium (0.5mg/Kg). For maintenance of anaesthesia, oxygen with isoflurane will be used and MAC of isoflurane will be maintained between 1.0-1.2. Duration of surgery, intraoperative heart rate, end tidal carbon dioxide, pulse oximeter reading, non invasive blood pressure and MAC of isoflurane will be recorded at 1 min interval for first five minutes and thereafter every 10 minutes throughout the procedure. Throughout the surgery, end tidal carbon dioxide will be maintained between 35-40mmHg. Before the end of surgery, all patient’s will receive injection diclofenac (1.5mg/Kg) and inj ondansetron 4mg to prevent post operative nausea and vomiting. At the end of surgery, patient’s trachea will be extubated when fully awake after reversing neuromuscular blockade with injection neostigmine (0.5mg/kg) and injection glycopyrrolate (0.01mg/kg). Time from discontinuation of agents to extubation will be recorded as extubation time and modified Aldrete score (Appendix II) will be assessed every five minutes after shifting the patient to recovery room till it reaches a value of 9. Post operative pain will be assessed using NRS and any patient reporting NRS>3 will be given rescue analgesic injection morphine 0.05mg/kg at 1, 2 and 4 hours postoperatively. At 8th and 24th hour postoperatively, patients will be assessed for postoperative pain using NRS, telephonically and any patient reporting NRS>3 will be advised rescue analgesic tablet paracetamol 1gm per oral. Post operative side effects like shivering, nausea, vomiting and agitation will also be recorded in recovery room. Also, the time when patient resumes oral intake will be recorded along with the time to meet the discharge criteria after day care surgery. (Appendix IV)
Statistical analysis
A total of sixty patients with diagnosis of primary infertility undergoing diagnostic hysterolaparoscopy will be enrolled for the study which will be stratified into low and high anxiety group based on their APAIS score. Thirty patients will be taken as age matched controls undergoing any other surgery under general anaesthesia. |