Tanta University hospitals
Tanta, 31511, Egypt
NCT Number: NCT04048226
* 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.
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Notify Me50 year–70 year
Female
Interventional
Phase 4
Tanta, 31511, Egypt
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.
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: -
All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 0.5 ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.
At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Normal saline infusion
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.
Other names: Intravenous anesthesia
Time frame: The first 24 hours postoperatively
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
Time frame: Through out the whole intraoperative period
The intraoperative consumption of fentanyl
Time frame: 6 months after the surgery
The patients who suffer from chronic pain during 6 months of follow up using simple questionnaire
Tanta University
Other
The Effect of Intraoperative Dexmedetomidine-Ketamine Infusion on the Patients Undergoing Radical Mastectomy: Randomized Controlled Study
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