Opioid use reducing effect of Ketamine-Dexmedetomidine vs. Ketamine-Magnesium Sulfate drug combinations in breast cancer surgeries

Opioid-sparing efficacy of Ketamine-Dexmedetomidine vs. Ketamine-Magnesium Sulfate combinations in breast cancer surgeries: A single blinded randomized study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/083984

Enrollment

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Injection Ketamine-Dexmedetomidine Intravenous infusion in the breast cancer patients undergoing Modified Radical mastectomy under general anaesthesia: For Group (K+D): Ketamine+ Dexmed

Injection Dexmedetomidine 1 mcg/kg Maintenance dose: Injection Ketamine 0.25 mg/kg/hour, Injection Dexmedetomidine 0.3-0.5 mcg/kg/hour. Control Intervention1: Injection Ketamine- Magnesium Sulfate

Injection Magnesium Sulfate 50 mg/kg Maintenance dose: Injection Ketamine 0.25 mg/kg/hour, Injection Magnesium Sulfate 8-10 mg/kg/hour.

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with breast cancer, undergoing modified radical mastectomy surgery under general anaesthesia, American society of Anaesthesiology (ASA) grade 1 and 2 patients, consented patients

Exclusion criteria

Exclusion criteria: ASA grade 3 and 4 cases. Non-consented patients. Any patient who will require elective post-operative mechanical ventilation due to any cause. Patients who are diagnosed case of any neuromuscular disorder. Patients in which the use of proposed drugs are contraindicated or patients having any allergy to the proposed drugs.

Design outcomes

Primary

Measure	Time frame
In breast cancer surgeries, to study the requirement of intraoperative injection fentanyl in terms of Morphine-milliequivalent (MME) for analgesia and maintaining haemodynamic stability in both the study groups. In breast cancer surgeries, to study requirement of post-operative injection Tramadol in terms of MME for pain control in both the study groups. Timepoint: In breast cancer surgeries, to study the requirement of intraoperative injection fentanyl in terms of Morphine-milliequivalent (MME) for analgesia and maintaining haemodynamic stability in both the study groups during whole of the surgical time. In breast cancer surgeries, to study requirement of post-operative injection Tramadol in terms of MME for pain control in both the study groups, at 6th, 12th, 24th and 48th hour post-operatively.	—

Measure

Time frame

In breast cancer surgeries, to study the requirement of intraoperative injection fentanyl in terms of Morphine-milliequivalent (MME) for analgesia and maintaining haemodynamic stability in both the study groups. In breast cancer surgeries, to study requirement of post-operative injection Tramadol in terms of MME for pain control in both the study groups. Timepoint: In breast cancer surgeries, to study the requirement of intraoperative injection fentanyl in terms of Morphine-milliequivalent (MME) for analgesia and maintaining haemodynamic stability in both the study groups during whole of the surgical time. In breast cancer surgeries, to study requirement of post-operative injection Tramadol in terms of MME for pain control in both the study groups, at 6th, 12th, 24th and 48th hour post-operatively.

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Secondary

Measure	Time frame
In both the study groups, to evaluate acute pain scores with the help of visual analogue scale (VAS) & NRS in the post-operative period for 6, 12, 24 & 48 hours. To assess haemodynamic parameters intra-operatively in both the study groups (Pulse rate, mean arterial pressure at the time of incision). To study the emergence from anaesthesia (time taken from neuromuscular blockade reversal to opening of eyes/following commands) in both study groups. To assess patient satisfaction with the help of Likert satisfaction scoring system, Postoperative nausea vomiting (PONV), any complaints of itching, initiation of mobilisation, initiation of enteral feeds. Timepoint: To evaluate acute pain scores with the help of VAS & NRS in the post-operative period for 6, 12, 24 & 48 hours. To assess haemodynamic parameters intra-operatively(Pulse rate, mean arterial pressure before & after induction & after incision). To study the emergence from anaesthesia at the end of surgery. To assess patient satisfaction with the help of Likert satisfaction scoring system, PONV, itching, initiation of mobilisation & enteral feeds for 48 hours in post-op.	—

Measure

Time frame

In both the study groups, to evaluate acute pain scores with the help of visual analogue scale (VAS) & NRS in the post-operative period for 6, 12, 24 & 48 hours. To assess haemodynamic parameters intra-operatively in both the study groups (Pulse rate, mean arterial pressure at the time of incision). To study the emergence from anaesthesia (time taken from neuromuscular blockade reversal to opening of eyes/following commands) in both study groups. To assess patient satisfaction with the help of Likert satisfaction scoring system, Postoperative nausea vomiting (PONV), any complaints of itching, initiation of mobilisation, initiation of enteral feeds. Timepoint: To evaluate acute pain scores with the help of VAS & NRS in the post-operative period for 6, 12, 24 & 48 hours. To assess haemodynamic parameters intra-operatively(Pulse rate, mean arterial pressure before & after induction & after incision). To study the emergence from anaesthesia at the end of surgery. To assess patient satisfaction with the help of Likert satisfaction scoring system, PONV, itching, initiation of mobilisation & enteral feeds for 48 hours in post-op.

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Countries

India

Contacts

Public ContactDr Shikha Jain

AIIMS Bhopal

shikha.anaesth@aiimsbhopal.edu.in7987164388

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026