A study to compare the effect of 3 opioid drugs on blood pressure,heart rate,respiratory rate etc during surgery and to see its effectiveness in controlling pain during and 6 hours after surgery

A comparative study of intravenous Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response to intubation and post-operative analgesia in modified radical mastectomy- A prospective randomized control study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025694

Enrollment

Registered

2020-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: Intravenous opioid prior to intubation in 3 different groups.: 3 groups receiving IV Fentanyl,Nalbuphine,Butorphanol prior to intubation respectively. Intervention2: IV Nalbuphine: IV N

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with breast carcinoma posted for modified radical mastectomy aged between 18-65 years ,giving valid informed consent belonging to ASA I and II.

Exclusion criteria

Exclusion criteria: Patient refusal or patients in ASA III or IV grade or having history of allergy to opioid group of drugs.

Design outcomes

Primary

Measure	Time frame
Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2. post operative analgesia for 6 hours after completion of surgery. Visual analogue scaleTimepoint: Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours	—

Measure

Time frame

Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2. post operative analgesia for 6 hours after completion of surgery. Visual analogue scaleTimepoint: Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours

—

Secondary

Measure	Time frame
Post operative Analgesia-visual Analogue scale(VAS) for pain assessment,systolic blood pressure,diastolic blood pressure,mean blood pressure,respiratory rate,SPO2Timepoint: 6 hours postoperatively	—

Countries

India

Contacts

Public ContactBeas Mukherjee

Kidwai Memorial Institute of Oncology

drshashi_2007@yahoo.co.in9008028611

Outcome results

None listed

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