COMPARISON OF INTRAVENOUS DEXAMETHASONE VERSUS NEBULIZATION WITH DEXAMETHASONE IN REDUCING POST OPERATIVE SORE THROAT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- To compare the post operative sore throat (POST) incidence between two groups in first 24 hours
研究概览
简要总结
Postoperative sore throat(POST) is common after endotracheal intubation making the patients uncomfortable and anxious in post operative period. POST is a common complication after general anaesthesia. Though considered to be a minor complication by most of the clinicians it may be quite distressing for the patient.Post operative sore throat results in cough.Cough after any surgery causes strains at the suture site increasing pain at the site of surgery and thus further adding to patients discomfort and dissatisfaction.It also adds to patients morbidity and making post operative period a bad memory for the patient. Hoarseness is also known to occur after endotracheal intubation. This change in voice may range from mild hoarseness noted by the patient to complete aphonia.
PROCEDURE: After hospital ethical committee approval patients who are satisfying the inclusion criteria will be selected after prior pre-anaesthetic check up. Patients will be randomly assigned into two equal groups,i.e,GROUP N and GROUP I using computer generated random sequencing software and provided to an assistant in sealed opaque envelopes.
GROUP N: They will receive 2 ml(8 mg) DEXAMETHASONE nebulisation and 2 ml 0.9 % saline intravenously.
GROUP I: They will receive 2 ml (8 MG) OF i.v DEXAMETHASONE and nebulisation with 2 ml 0.9 % NACL
The drug volume in both the group will be the same ( nebulisation/intravenous).
Before 30 minutes of commencement of surgery , the patient in group N will be nebulised with 2 ml of dexamethasone and 2 ml 0.9% NACL given intravenously and viceversa in group I by the assistant.
After the OT patient shifted to PACU where PR BP RR SPO2 monitored for 24 hours where incidence of POST,PONV,HOARSENESS will be recorded at 1hr,6hr,12hr,24hr postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.ASA classification 1 & 2 2.All genders 3.Patients posted for elective laparoscopic cholecystectomy uder general anaesthesia with endotracheal intubation.
- •4.Duration of surgery less than 2 hours 5.Patients willing to give informed and written consent.
排除标准
- •1.history of allergic reactions to DEXAMETHASONE.
- •2.Patients on steroids already.
- •4.Patients who would require manipulation or instrumentation of airway.
- •5.patients who need second attempt during ET tube insertion.
- •6.Patients with sore throat/URTI/hoarseness.
- •7.patients with Cormack Lehane grade 4.
结局指标
主要结局
To compare the post operative sore throat (POST) incidence between two groups in first 24 hours
时间窗: at 1hr,6hr,12hr,24 hours after surgery
次要结局
- 1.To compare the incidence of hoarseness & grade of hoarseness between two groups(2.To compare the incidence of postoperative nausea & vomiting (PONV)between two groups)