Dexmedetomidine-Ketamine Infusion in Breast Surgeries

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

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

Dexmedetomidine-Ketamine group 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.

Study Overview

• Status: Completed
• Conditions: Total Intravenous Anesthesia
• Intervention / Treatment: Drug: Placebos; Drug: Dexmedetomidine +Ketamine

Detailed 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-II, 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 (30 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 1ug/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 intraopeartively.
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 6 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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31511
    • Tanta University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients aged 50-70 years, ASA class I-II, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 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.	Drug: Placebos; 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
Experimental: Dexmedetomidine-Ketamine group; 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.	Drug: Dexmedetomidine +Ketamine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative morphine consumption	The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4	The first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the chronic pain	The patients who suffer from chronic pain during 6 months of follow up using simple questionnaire	6 months after the surgery
The intraoperative fentanyl consumption	The intraoperative consumption of fentanyl	Through out the whole intraoperative period

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sameh Ismaiel, M.D, Lecturer of Anesthesia and Intensive Care, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; Ketamine; Dexmedetomidine; Radical Mastectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: 33108/05/19; Tanta University (Other Identifier: Faculty of Medicine, Tanta University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No