Comparison of two medicines namely Inj Dexmedetomidine and Inj Dexamethasone for vomiting prevention in patients undergoing back bone surgeries.(To find which among the two medicines is better for the purpose of vomiting prevention after the surgery)
- Conditions
- Discitis, unspecified,
- Registration Number
- CTRI/2020/04/024816
- Lead Sponsor
- Dr Ramyavel Thangavelu
- Brief Summary
The incidence of Post operative nausea vomiting (PONV) is especially high in high risk patients, one of them being patients undergoing spine surgery. Multimodal therapy with a combination of antiemetics like 5 HT3 antagonists combined with phenothiazines, antihistamines and steroids is the preferred modality for PONV prevention in high risk patients. Recently the effect of dexmedetomidine , an alpha 2 agonist, has been the focus of clinical researches. we aimed to evaluate the efficacy of dexmedetomidine when used as an adjuvant to ondansetron for PONV and compare it with dexamethasone ondansetron combination. After getting institutional ethical committee clearance, 100 patients of age group 18 to 70 years will be enrolled in the study. After standard induction,intubation and positioning the patient prone, the study group will receive either 5 ml saline bolus followed by Inj dexmedetomidine infusion continued throughout the period of surgery or Inj Dexamethasone 0.1 mg/kg as 5 ml bolus follwoed by saline infusion throughout the surgery. The anaesthetist blinded to the study will be recording the hemodynamics (HR, MAP) , total dose of opioid and inhalational agent received intraoperatively. After reversal and extubation, patients will be shifted to recovery and followed up every four hours for 24 hours for the presence of PONV and the total rescue antiemetic received.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
All patients aged 18-70 years belonging to ASA 1 and 2 undergoing elective spine surgery under general anaesthesia.
- 1)Any allergy/hypersensitivity to the study medication.
- 2)Patients with BMI > 30 kg/m2 3)Patients for emergency spine procedures.
- 4)Patients who received opioid, antiemetics or any steroid therapy 24 hrs prior to surgery.
- 5)Patients had episode of nausea, vomiting or retching in the 24 hrs prior to anaesthesia.
- 6)Patients with history of GERD.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade of Post operative nausea vomiting Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs (Grade 0: no nausea and no retching Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs Grade 1: complaining of sickness or retching Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs Grade 2: vomiting one or two times in 30 minutes Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs Grade 3: vomiting more than two times in 30 minutes Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
- Secondary Outcome Measures
Name Time Method 1. Mean arterial pressure (MAP)and Heart rate (HR). 2.Dose of additional Inj fentanyl administered
Trial Locations
- Locations (1)
Pondicherry Institute of medical sciences
🇮🇳Pondicherry, PONDICHERRY, India
Pondicherry Institute of medical sciences🇮🇳Pondicherry, PONDICHERRY, IndiaDr Ramyavel ThangaveluPrincipal investigator9487630425ramyavel1988@gmail.com