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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)

Comparison of Dexmedetomidine and Dexamethasone as an adjuvant to ondansetron for prevention of postoperative nausea vomiting in patients undergoing elective spine surgery- A Randomised Double blind Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024816
Enrollment
100
Registered
2020-04-23
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: M464- Discitis, unspecified

Interventions

Intervention1: Inj Dexmedetomidine: Inj Dexmedetomidine as a continuous infusion at the rate of 0.2 mcg/kg/hr initiated at the start of surgery continued till skin closure. Control Intervention1: Inj

Sponsors

Dr Ramyavel Thangavelu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients aged 18-70 years belonging to ASA 1 and 2 undergoing elective spine surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Grade of Post operative nausea vomiting (Grade 0: no nausea and no retching Grade 1: complaining of sickness or retching Grade 2: vomiting one or two times in 30 minutes Grade 3: vomiting more than two times in 30 minutes Timepoint: 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

MeasureTime frame
1. Mean arterial pressure (MAP)and Heart rate (HR). 2.Dose of additional Inj fentanyl administered 3. Concentration of inhalational agent used. 4. Grade of Sedation postoperatively. Timepoint: MAP, HR, Inj Fentanyl and Conc of Inhalational agent will be assessed at: Baseline (at start of surgery) followed by every 30 min till the end of surgery. Grade of sedation will be assessed at: At baseline (immediately post surgery) followed by every 4 hrs till 24 hrs post surgery.

Countries

India

Contacts

Public ContactDr Ramyavel Thangavelu

Pondicherry Institute of Medical Sciences

ramyavel1988@gmail.com9487630425

Outcome results

None listed

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