A study to see if giving Magnesium sulfate through a drip during breast cancer surgery helps women wake up more calmly and recover better after the operation.

Evaluation of the effects of Intraoperative IV infusion of Magnesium sulfate on Emergence Agitation and Recovery characteristics in Female patients undergoing Breast Cancer Surgeries - A Prospective Randomized Controlled Study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088960

Enrollment

Registered

2025-06-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Interventional Group : Magnesium Sulfate: Intraoperatively in the magnesium group, patients received a 30 mg/kg bolus of Intravenous Magnesium Sulphate within one hour after induction a

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1.Female patients aged 18 to 65 years. 2.Diagnosis of breast cancer necessitating surgeries. 3.American Society of Anesthesiologists (ASA) physical status Classification I or II, indicating patients with mild systemic disease or those with no systemic disease. 4.Ability to provide informed consent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The primary objective: a) To Quantify the incidence and severity of emergence agitation using Riker s sedation agitation scale.Timepoint: T0 : Point at which sevoflurane is cut off T1: Point where reversal agent is given T2 : 2 mins after administration of reversal TE : Point of extubation T3 :2 mins after extubation T4 : 5 mins after extubation T5 : 10 mins after extubation T6 : 30 mins after extubation	—

Measure

Time frame

The primary objective: a) To Quantify the incidence and severity of emergence agitation using Riker s sedation agitation scale.Timepoint: T0 : Point at which sevoflurane is cut off T1: Point where reversal agent is given T2 : 2 mins after administration of reversal TE : Point of extubation T3 :2 mins after extubation T4 : 5 mins after extubation T5 : 10 mins after extubation T6 : 30 mins after extubation

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Secondary

Measure	Time frame
The secondary objectives: a) To Investigate recovery Characteristics like reaction time (the time period between the point where sevoflurane is cut off & the point where regain of consciousness), recovery time (the time period between the point where sevoflurane is cut off & the point where extubation is done). b) To observe the hemodynamic changes at extubation c) To assess the pain (vas score) & rescue analgesia within 30mins in post operative period. d) To observe for post-extubation complications & magnesium sulphate related complications.Timepoint: T0 , T1 , T2 , TE, T3,T4,T5,T6 ( As same as time points of primary outcome )	—

Measure

Time frame

The secondary objectives: a) To Investigate recovery Characteristics like reaction time (the time period between the point where sevoflurane is cut off & the point where regain of consciousness), recovery time (the time period between the point where sevoflurane is cut off & the point where extubation is done). b) To observe the hemodynamic changes at extubation c) To assess the pain (vas score) & rescue analgesia within 30mins in post operative period. d) To observe for post-extubation complications & magnesium sulphate related complications.Timepoint: T0 , T1 , T2 , TE, T3,T4,T5,T6 ( As same as time points of primary outcome )

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Countries

India

Contacts

Public ContactDr T NAVEEN KUMAR

Nizams Institute Of Medical Sciences, Hyderabad

narmadapadhy1@gmail.com9392408465

Outcome results

None listed

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