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Study to see the requirement of of Pain injection dose in Breast Surgery

Not yet recruiting
Conditions
Medical and Surgical,
Registration Number
CTRI/2022/07/043777
Lead Sponsor
Nizams Institute of Medical sciences
Brief Summary

After obtaining institutional ethical commitee approval and CTRI acknowledgement number, and written informed consent from patients, A prospective randomised controlled study will be conducted in 30  ASA I-II female patients aged 18 to 65 years undergoing mastectomy under general anaesthesia  and amount of fentanyl consumption will be compared between haemodynamic and SPI guidance.  Patients refusing, allergic to fentanyl, hypertension, on beta blockers, cvs, CNS, renal  and respiratory diseases will be excluded. Patients will be advised fasting 8 hours before surgery and administered rantac and alprozolam tablets. Later the patients will be shifted to OT, connected to monitors: NIBP, ECG, SPI, spo2, ETCO2 and IV fluid administered, Baseline VITALS: HR, RR, SPO2, SBP.DBP, MAP noted. Patients will be premedicated with iv fentanyl, glycopyrolate, induced and later intubated and connected to ventilator. Vitals will be noted every 5 minutes till end of surgery and fentanyl requirement will be recorded.  Later at the end of surgery patient will be extubated.  Degree of postop pain, dose of first rescue analgesic requirement , extubation and any adverse events will be noted.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
30
Inclusion Criteria

1.18 – 65 years 2.ASA grade I and II 3.Females 4.Scheduled for elective mastectomy.

Exclusion Criteria

1.Patient Refusal 2.Known allergy to Fentanyl drug 3.Hypertension & those on beta blockers 4.Cardiovascular disease, Cardiac arrhythmias, drugs influencing HR, Pacemakers 5.Previous Sympathectomy, Vagotomy 6.Respiratory disorder like asthma 7.Neurologic disorders like Seizures 8.Renal disease 9.Patients on chronic medication like analgesics or psychiatric medication.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
intraoperative dose of fentanyl requirementbaseline till end of surgery
Secondary Outcome Measures
NameTimeMethod
1.postop rescue analgesic requirement2. extubation time

Trial Locations

Locations (1)

Nizams institute of medical sciences

🇮🇳

Hyderabad, TELANGANA, India

Nizams institute of medical sciences
🇮🇳Hyderabad, TELANGANA, India
Singam Geetha
Principal investigator
9441043075
singamgeetha11@gmail.com

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