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

Phase 2

Not yet recruiting

Conditions: Malignant neoplasm of breast, (2) ICD-10 Condition: C50||Malignant neoplasm of breast,

Registration Number: CTRI/2020/06/025694

Lead Sponsor: Beas Mukherjee

Brief Summary: Opioids are popular and widely used adjuvant agent in conducting generalanasthesia. Fentanyl is extensively used due to its rapid onset of action, shorterduration of action and predictable pharmacokinetics and dynamics but it has tobe bought under opioid registry and have serious side effect of respiratorydepression. On the other hand, Nalbuphine and Butorphanol being partialagonist-antagonist at opioid receptors has no respiratory depression activityand are not under opioid regulation. But there are inadequate studies of safetyand efficacy of the above mentioned drugs in Indian population.so our aim ofthe study is to study the effect of equivalent intravenous dose of Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response due tointubation and post-operative analgesia in modified radical mastectomy(MRM)surgeries. Primary objective of our study is to compare the haemodyanamic response of Fentanyl, Nalbuphine and Butorphanol. Our secondary objective is to assess post-operativeanalgesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 90

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2.	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
post operative analgesia for 6 hours after completion of surgery.	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
Visual analogue scale	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 Outcome Measures

Name	Time	Method
Post operative Analgesia-visual Analogue scale(VAS) for pain assessment,systolic blood pressure,diastolic blood pressure,mean blood pressure,respiratory rate,SPO2	6 hours postoperatively

Trial Locations

Locations (1): Room No. 105 ,Department of Anaesthesiology and pain reliefKidwai Memorial Institute of Oncology
🇮🇳
Bangalore, KARNATAKA, India
Room No. 105 ,Department of Anaesthesiology and pain reliefKidwai Memorial Institute of Oncology
🇮🇳Bangalore, KARNATAKA, India
Beas Mukherjee
Principal investigator
08811802902
alipore62@gmail.com