Dexmedetomidine-Ketamine Infusion in Breast Surgeries

NCT04048226 | Completed Phase 4

• 2 other identifiers: 33108/05/19Tanta University
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Intravenous Anesthesia

Keywords

Dexmedetomidine; Ketamine; Radical Mastectomy; Chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The intraoperative fentanyl consumption

  Through out the whole intraoperative period

• Incidence of the chronic pain

  6 months after the surgery

Study Arms (2)

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.

Drug: Placebos

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.

Drug: Dexmedetomidine +Ketamine

Interventions

Placebos DRUG

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.

Also known as: Normal saline infusion

Control group

Dexmedetomidine +Ketamine DRUG

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.

Also known as: Intravenous anesthesia

Dexmedetomidine-Ketamine group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Participant eligibility is not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Anesthesia, Intravenous

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: September 1, 2019
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)