Health Condition 1: O- Medical and Surgical Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Dexamethasone: The study arm will receive dexamethasone 6 mg or 0.1mg/kg, whichever is lower, diluted up to two millilitres by normal saline within one hour of induction.
Control Interv
Sponsors
Tata Memorial Hospital, Mumbai, India
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 to 80 years undergoing minimally invasive oesophagectomy (Video Assisted Thoracoscopic Surgery / Robotic)
Exclusion criteria
Exclusion criteria: 1. Contraindications to Dexamethasone- a) Diabetic patients with HbA1c more than 6, patients requiring insulin therapy b) Patients with evidence of preoperative infection suggested by fever, radiological signs suggestive of infection in the chest, deranged CRP, PCT, WBC more than 11,000 or less than 4000. c) Patients on chronic steroid therapy. 2. Chronic therapy with opioids, drug addiction, or a history of drug abuse. 3. Contraindications to diclofenac- a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine 1. Contraindications to Dexamethasone- a) Diabetic patients with HbA1c more than 6, patients requiring insulin therapy b) Patients with evidence of preoperative infection suggested by fever, radiological signs suggestive of infection in the chest, deranged CRP, PCT, WBC more than 11,000 or less than 4000. c) Patients on chronic steroid therapy. 2. Chronic therapy with opioids, drug addiction, or a history of drug abuse. 3. Contraindications to diclofenac- a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine more than 1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy, b) Deranged renal function tests ?serum creatinine value more than 1.5mg / dl c) Patients with low platelet counts ( less than 75,000 per microlitre) d) Patients with a history of peptic ulcer disease, e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma. 4. Contraindication to Paracetamol -liver dysfunction- Child ? Pugh ? Turcotte score of class B (value 7 ? 9 ) and above, indicating moderately impaired hepatic function 1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy, b) Deranged renal function tests ?serum creatinine value more than 1.5mg / dl c) Patients with low platelet counts ( less than 75,000 per microlitre) d) Patients with a history of peptic ulcer disease, e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma. 4. Contraindication to Paracetamol -liver dysfunction- Child ? Pugh ? Turcotte score of class B (value 7 ? 9 ) and above, indicating moderately impaired hepatic function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To calculate the total opioid consumption (in terms of morphine equivalents) in the post operative periodTimepoint: First 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (0-10) for pain at rest ( NRS REST), Numeric Rating Scale after exercise ( NRS EXERCISE ), Maximum inspiratory efforts on spirometer at predefined time intervalsTimepoint: 1-4 hours, 4-8 hours, 8-12 hours, 20-24 hours, 30-36 hours and 44- 48 hours after the surgery;The worst pain NRSTimepoint: at 24 hours and 48 hours;Episodes of hyperglycaemia (blood sugar levels above 180 mg/dl)Timepoint: up to 48 hours;Episodes of post-operative nausea, vomitingTimepoint: Till 48 hours post surgery;Incidence of ? Surgical wound infection Infective pulmonary complications Anastomotic leak Status of the patient CLVIEN DINDO score Timepoint: Till hospital discharge | — |
Countries
India
Contacts
Public ContactDr Indulekha Menon
Tata Memorial Hospital
Outcome results
None listed