Comparison between two antiemetics (ondansetron and ramosetron) in the prevention of Post operative nausea and vomiting
- Conditions
- Malignant neoplasm of brain, unspecified, The patients undergoing Craniotomy(Intra-cranial neoplasm, Traumatic brain Injury)were assessed for Post-Operative Nausea and Vomiting for 48 Hours,
- Registration Number
- CTRI/2018/01/011345
- Lead Sponsor
- Obaid Ahmad Siddiqui
- Brief Summary
Weconducted a prospective,randomized, double-blinded study to compare the efficacy of Ondansetron withRamosetron in preventing early (0-24 hours) and delayed (24-48 hours)post-operative nausea and vomiting (PONV) in 130 patients undergoing craniotomyunder general anaesthesia.
The study was conducted after obtaininginstitutional ethical committee clearance and written informed consent from allpatients. Thorough pre-anaesthetic evaluation was done, investigations werenoted.
Patients were randomized into two groups,ondansetron group (control group) and ramosetron group (study group) of 65patients each using a computer generated randomization table.
Patients in both the groups were administeredgeneral anaesthesia using the same anaesthetic protocol. Patients in controlgroup were given Injection ondansetron 4mg IV while patients in study groupreceived injection ramosetron 0.3 mg IV 30 minutes before closure of skin.
In the post-operative period, patients were monitored for nausea,vomiting, pain and vital signs. Patients were closely monitored for 48 h andany complaint of nausea, retching, and vomiting or adverse drug effect wasrecorded by an independent observer (usually a Resident Doctor) who was blindedto the study. Inj. Metoclopramide (0.15 mg/kg I.V.) was administered as anadditional rescue antiemetic in patients with two or more than two episodes ofvomiting and/or significant nausea at any time within 48 hours of operation.Exact timing of the administration of the rescue antiemetic was recorded.
Patients in both the groups werefound to be comparable in terms of age, height, weight, ASA status, nature ofsurgery (tumour/vascular), pre-operative heart rate and mean arterial pressure(MAP) with no statistical significance.
Also, all the patients underwent craniotomiesand the mean duration of anaesthesia and the mean duration of surgery were alsocomparable with no statistical significance.
The incidence and severity ofdelayed vomiting and retching were significantly lesser in Ramosetron group ascompared to Ondansetron group.
Sofrom our study we derive that Ramosetron is better than ondansetron atpreventing delayed PONV (24-48 Hours) after craniotomy under generalanaesthesia. However, both the drugs are comparable in preventing early PONV(0-24 Hours). The incidence of side effects is similar in Ondansetron andRamosetron.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
- 1.ASA I & II patients.
- 2.Mallampatti grades I & II.
- 1.Patients with a history of motion sickness, Gastroesophageal Reflux Disease (GERD).
- 2.Patients with major Cardiovascular Disease, Respiratory Disease and uncontrolled diabetes mellitus.
- 3.Patients with anticipated difficult intubation.
- 4.History of alcohol, drug abuse or smokers.
- 5.Post operative Glasgow Coma Score (GCS) less than 8.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - POST OPERATIVE NAUSEA AND VOMITING. -NAUSEA VOMITING RETCHING
- Secondary Outcome Measures
Name Time Method SIDE EFFECTS OF DRUGS USED Dizziness
Trial Locations
- Locations (1)
Jawaharlal Nehru Medical College,Aligarh Muslim University
🇮🇳Aligarh, UTTAR PRADESH, India
Jawaharlal Nehru Medical College,Aligarh Muslim University🇮🇳Aligarh, UTTAR PRADESH, IndiaHASSANPrincipal investigator9997792731Hassandoc90@gmail.com