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临床试验/NCT04048226
NCT04048226已完成4 期

The Effect of Intraoperative Dexmedetomidine-Ketamine Infusion on the Patients Undergoing Radical Mastectomy: Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
103
试验地点
1
主要终点
The postoperative morphine consumption

研究概览

简要总结

  • This is a prospective randomized double blind controlled study.
  • Female patients undergoing radical mastectomy will be included in this study where they will be randomly allocated into; - Control group in which patients will receive continuous infusion of normal saline.

Dexmedetomidine-Ketamine group in which patients will receive continuous infusion of ketamine and dexmedetomidine.

The intraoperative and postoperative opioid consumption will be measured. Also, the postoperative pain score and the incidence of chronic pain will be assessed.

详细描述

This prospective randomized controlled study will be carried out on 70 female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

-Inclusion criteria: Female patients aged 50-70 years, ASA class I-III, and presented for elective radical mastectomy.

  • Exclusion criteria: Patients refused to participate. Patients with known or suspected or known allergy to the used medication. Patients with preoperative chronic pain, Patients received preoperative opioids or gabapentoids. Patients with major cardiac, renal, respiratory, or hepatic disease. Uncooperative patients. Obese patients with BMI >36

Anesthetic technique Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. An assistant anesthetist will help in preparation of a 50 ml syringe connected to a syringe pump that will contain normal saline or a mixture of 100 ug dexmedetomidine and 50 mg ketamine.

Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36 mmHg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min). The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization: -

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

  • The patients will be blind through the use of closed sealed envelops.
  • The investigator will be blind through the use of syringe pump containing normal saline in the control group by the aid of anesthesia resident who will not participate in the study.
  • The measurement will be collected by anesthesia nurse not participating in the study and blinded to its group.

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 50-70 years, ASA class I-III, and presented for elective radical mastectomy.

排除标准

  • Patients refused to participate.
  • Patients with known or suspected or known allergy to the used medication.
  • Patients with preoperative chronic pain,
  • Patients received preoperative opioids or gabapentoids.
  • Patients with major cardiac, renal, respiratory, or hepatic disease.
  • Uncooperative patients.
  • Obese patients with BMI >36

研究组 & 干预措施

Control group

Placebo Comparator

The patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.

干预措施: Placebos (Drug)

Dexmedetomidine-Ketamine group

Experimental

The patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.

干预措施: Dexmedetomidine +Ketamine (Drug)

结局指标

主要结局

The postoperative morphine consumption

时间窗: The first 24 hours postoperatively

The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4

次要结局

  • Incidence of the chronic pain(6 months after the surgery)
  • The intraoperative fentanyl consumption(Through out the whole intraoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Tanta University

研究点 (1)

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