A Randomised Prospective double blinded Observational study to Compare the Post General Anaesthesia recovery with Pentazocine and Fentanyl groups along with other preanaesthetic medications in a tertiary care hospital at Puducherry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To compare the incidence of postoperative pain, nausea/vomiting and sore throat between fentanyl and pentazocine groups
研究概览
简要总结
Patients were selected based on the inclusion criteria and those who are selected were explained about the study and procedure involved and informed written consent will be obtained. Patients who have given consent will be randomly divided into two groups by sealed envelope technique (i.e) Group (P) and Group (F). Group (P) will be given Pentazocine along with fixed standard preanesthetic medication and Group(F) will be given Fentanyl along with fixed standard preanesthetic medication. All the selected patients will be assessed preoperatively and demographic data will be collected and they will be given the preanesthetic medications and they will undergo surgery and they will be monitored in the postoperative ward for the incidence of pain, nausea/vomiting, sore throat and delirium, respiratory depression, hoarseness of voice, cough for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18-60yrs.
- •Patients of both gender.
- •Patients with BMI 18.5 -22.9 (acc.
- •to WHO Asian BMI scale )
- •Patients with controlled hypertension.
- •Patients with controlled Diabetes mellitus.
- •Patients with controlled hypothyroid.
- •Patients who are given Opioid free analgesia except induction.
- •Patients undergoing surgeries under plain General Anaesthesia with duration of 2-3hrs (like breast surgeries, CSOM (Chronic suppurative Otitis Media) surgeries, spine and other minor orthopedic surgeries, Total Abdominal Hysterectomy with Bilateral Salphingo-Oophorectomy, Appendicectomy, Herniorrhaphy, lymph node excision on neck.,) 9.
排除标准
- •Patients with following comorbidities (Acid Peptic Disease, Asthma, Pulmonary edema, Pulmonary fibrosis, Coronary artery disease)
- •Patients with difficulty airway.
- •Patients with known psychiatric illness.
- •Patients undergoing surgery with Duration of more than 3hrs.
- •Patients undergoing Laparoscopic surgery, adenotonsillectomy and other oral surgery.
- •Patients who are developing intraoperative events such as somatic arousal, pain perception, tachy/bradycardia.
结局指标
主要结局
To compare the incidence of postoperative pain, nausea/vomiting and sore throat between fentanyl and pentazocine groups
时间窗: Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward.
次要结局
- To compare the incidence of Delirium, Respiratory depression,hoarseness of voice, cough between pentazocine and fentanyl groups.(Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward.)
研究者
Dr Snegaamarane K
Sri Venkateshwaraa Medical College Hospital and Research Centre