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Comparison Of Two Drugs For Prevention Of Post Operative Nausea Vomiting During Middle Ear Surgery

Comparison of efficacy of palonosetron - dexamethasone combination with palonosetron or dexamethasone alone for prophylaxis against post operative nausea and vomiting in patients undergoing middle ear surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021157
Enrollment
150
Registered
2019-09-09
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: H66- Suppurative and unspecified otitismedia

Interventions

Intervention1: Group P (Intervention Agent) : Group P : Patients will receive Palaonosetron 0.075mg(1.5ml) + Norml saline (8.5ml) - total volume 10 ml Intervention2: Group PD (Intervention Agents):

Sponsors

Department Of Anesthesiology And Critical Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients Belonging To American Society Of Anaesthesiology(ASA) Grade 1 And 2 , And Of Age Group 18 TO 60 Years With Body Weight 40 TO 80 Kg Of Either Sex Undergoing Middle Ear Surgery And Willing To Give A Written And Informed Consent.

Exclusion criteria

Exclusion criteria: 1 Pregnant and lactating females or patients having huge abdominal mass or tumour. 2 A cancer patient who has had chemotherapy within 4 weeks prior to study entry (Screening visit) or any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit). 3 Patients who had received any investigational drugs within 30 days before study entry or taken any drug with potential antiemetic efficacy within 24 hours prior to anaesthetic procedures. 4 Patients who have history of any vomiting, retching, or nausea in the 24 hours preceding the administration of anaesthesia. 5 Patients who have current history of alcohol abuse or drug abuse or taking any hormonal supplements. 6 Patients having hypersensitivity/contraindication to 5-HT3 antagonists or study drug. 7 Patients having cardio respiratory dysfunction or renal, hepatic or metabolic derangements or history of epilepsy. 8 Patients with Ryleâ??s tubes in situ. 9 Patients in varying degrees of shock during pre and post operative period. 10 Patients who will require any opioid analgesic for post operative pain relief during the period of study.

Design outcomes

Primary

MeasureTime frame
Post Op Nausea VomitingTimepoint: Immediately After Shifting In PAC , Than After 1 Hrs , 4 Hrs , 12 Hrs , 24 Hrs Post Op—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDR SHIKHA SONI

Dr. S.N. Medical College,Jodhpur, Rajasthan

takml88@gmail.com9799622552

Outcome results

None listed

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