Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04048226 |
Other study ID # |
33108/05/19 |
Secondary ID |
Tanta University |
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
March 20, 2024 |
Study information
Verified date |
April 2024 |
Source |
Tanta University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
- 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.
Description:
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: -
• Control group (35 patients): 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.
• Dexmedetomidine-Ketamine group (35 patients): 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.
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.
- Measurements:
1. Patient age, weight, height.
2. Morphine consumption in the first 24 h postoperatively.
3. The total dose consumption of fentanyl consumed intraoperatively.
4. The total volume consumed of isoflurane intraoperatively (ml/hr).
5. The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 8
h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia
will be administrated in the form of 3 mg morphine i.v that may be repeated.
6. The time for the first request of morphine rescue analgesia
7. The incidence of chronic pain (Follow up of the patients will be carried out in the pain
clinic after discharge from hospital every 2 weeks for a period of 6 months for
assessment of the incidence of postoperative chronic pain.
8. The recovery profile
9. The incidence of complications