A comparative clinical trial comparing three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Primary objectives: to compare the following parameters:
研究概览
简要总结
In the present study we aim to evaluate and compare different parameters in three groups of patients receiving different maintenance doses of dexmedetomidine during third molar extraction surgery and to determine the ideal maintenance dose of Dex suitable for sedation with minimal side effects and early discharge from the OPD of the Department of Oral and Maxillofacial Surgery , Dr. HSJ Institute of Dental Sciences, Chandigarh.
The three maintenance doses of Dexmedetomidine (0.2, 0.4 and 0.6 mcg/kg/hr) shall be compared for their hemodynamic and respiratory effects; onset and time of sedation (achieving a Ramsay score of ≥2 and Ramsay score of ≤2 after the procedure, respectively); Ramsay sedation scores during the procedure; recovery and discharge time.
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
- •ASA 1 patient Patient requiring 3rd molar extraction surgery under LA Patient willing for intravenous sedation during the procedure.
排除标准
- •Pregnant females Lactating mothers.
- •Patient with history of drug allergy to any drug.
- •Patient on any medication History of dental treatment phobia Abnormal gag reflex.
结局指标
主要结局
Primary objectives: to compare the following parameters:
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
2.Pain scores
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
4.Time of discharge of patient
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
3.Hemodynamic and respiratory effects
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
Secondary objectives: to compare the following parameters:
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
1.Amnesia
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
4.Duration of analgesia
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
3.Patient satisfaction score
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
2.Surgeon satisfaction score
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
5.Requirement of rescue sedation
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
6.Any other side effects noted during the procedure
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
1.Sedation scores
时间窗: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. | VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. | PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
次要结局
- 1. Amnesia(2. Surgeon satisfaction score)