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临床试验/CTRI/2024/08/072045
CTRI/2024/08/072045尚未招募不适用

Comparison Of Preoperative Anxiety In Adult Patients Undergoing Spinal Anesthesia Electively for the Second time Or more versus the ones for the first time: An observational study

Dr Chandramma Dayanand Sagar institute of medical education and research1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To compare anxiety scores in 2 groups (group E and group NE)

研究概览

简要总结

All patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire will be issued and scores noted in both groups. All the patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire (annexure 1). The questionnaire comprises of 6 questions, out of which first 2 questions gauge the anesthesia related anxiety, questions 5 and 6 gauge the surgery related anxiety, question 1,2,4 and 5 gauge the combined anxiety with surgery and anesthesia and lastly questions 3 and 6 throws light on the area of patient’s desire to know more about the procedure. Each of these questions will be given a response on a likert scale from score 1 to 5, which is described as "not at all" to " extremely" respectively. Any patient who has a score of over 11 will be prescribed tab Alprazolam 0.25mg on the night before surgery. On the day of surgery, as per hospital protocol, peripheral intravenous cannula will be secured and intravenous crystalloid infusion will be initiated. Following the premedication with proton pump inhibitor and antiemetic, patient will be wheeled in to the operation theatre. ASA standard monitoring will be done after positioning the patient supine on the operating table. The baseline clinical parameters viz., heart rate, blood pressure, respiratory rate and oxygen saturation will be recorded and documented in the clinical proforma. Under strict asepsis, in the sitting position, lumbar puncture will be performed with a 25 gauge Quincke Bob needle, following local infiltration of L3-L4 or L4-L5 intervertebral space with 2 ml of 2% lignocaine . After confirming the free flow of CSF, 12mg-15mg of 0.5% H- bupivacaine will be injected intrathecally. In less than 30 seconds, patient will be made to lie supine and will be tested for motor blockade and level of sensory blockade by standard clinical tests. Simultaneously the vital parameters will be recorded every 5 minutes in all patients.All the patients who are admitted in our hospital and who fulfill the inclusion criteria will be enrolled for the study. As a part of pre-anesthetic evaluation, all the patients will be visited by the anesthesiologist in their respective ward or in the pre-anesthesia clinic, at least a day before the surgery as per institutional protocol. The process and steps involved in the administration of subarachnoid blockade and surgery will be explained in their comprehensible language for all the patients. A special emphasis will be laid on obtaining the history of previous surgery, anesthesia, no. of days of ICU stay, discharge from recovery room, backache and other pain related to surgery, history of sleep disturbances. Before collection of data all the participants will be explained about the purpose and importance of conducting the study and after receiving the informed consent, the APAIS questionnaire will be handed over to them in a language preferred by the patient. All the participants will be assured regarding maintenance of confidentiality with respect to their Identity. Data collection will be done by the anesthesiologist, a day prior to the surgery in person using Amsterdam Preoperative Anxiety Informaton Scale (APAIS) questionnaire (annexure 1). The questionnaire comprises of 6 questions, out of which first 2 questions gauge the anesthesia related anxiety, questions 5 and 6 gauge the surgery related anxiety, question 1,2,4 and 5 gauge the combined anxiety with surgery and anesthesia and lastly questions 3 and 6 throws light on the area of patient’s desire to know more about the procedure. Each of these questions will be given a response on a likert scale from score 1 to 5, which is described as "not at all" to " extremely" respectively. Any patient who has a score of over 11 will be prescribed tab Alprazolam 0.25mg on the night before surgery. On the day of surgery, as per hospital protocol, peripheral intravenous cannula will be secured and intravenous crystalloid infusion will be initiated. Following the premedication with proton pump inhibitor and antiemetic, patient will be wheeled in to the operation theatre. ASA standard monitoring will be done after positioning the patient supine on the operating table. The baseline clinical parameters viz., heart rate, blood pressure, respiratory rate and oxygen saturation will be recorded and documented in the clinical proforma. Under strict asepsis, in the sitting position, lumbar puncture will be performed with a 25 gauge Quincke Bob needle, following local infiltration of L3-L4 or L4-L5 intervertebral space with 2 ml of 2% lignocaine . After confirming the free flow of CSF, 12mg-15mg of 0.5% H- bupivacaine will be injected intrathecally. In less than 30 seconds, patient will be made to lie supine and will be tested for motor blockade and level of sensory blockade by standard clinical tests. Simultaneously the vital parameters will be recorded every 5 minutes in all patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA PS I, ASA PS II and ASA PS III Patients between 18 years to 75 years of age Patients posted for elective surgery under subarachnoid blockade Patient who will give consent Patient who can read and write kannada or English Patients electively posted for gynaecological cases, elective cesereans, urogenital surgery, lower abdominal surgery, lower limb surgery.

排除标准

  • Patients with Mental Retardation, Dementia, Hearing and visual impairment Patients posted for amputation, surgery involving massive blood loss and multiple blood transfusion ASA 4 and above Patient refusal.

结局指标

主要结局

To compare anxiety scores in 2 groups (group E and group NE)

时间窗: Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery

E- exposed to spinal anesthesia

时间窗: Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery

NE Not exposed to spinal anesthesia

时间窗: Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery

Secondary outcomes postoperative pain control in 2 groups

时间窗: Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery

Level of blockade achieved in 2 groups

时间窗: Anxiety scores calculated by giving APAIS questionnaire atleast 24hrs prior to the surgery

次要结局

  • Level of blockade achieved in 2 groups(Level of postoperative pain control in 2 groups)

研究者

发起方
Dr Chandramma Dayanand Sagar institute of medical education and research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prajna Jayaram

CDSIMER, dayanand sagar university

研究点 (1)

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