The effect of ondansetron and dexmedetomidine in reducing nausea and vomiting

Comparative study of the preemptive Dexmedetomidine with Ondansetron effect in reducing the post-operative nausea and vomiting after elective middle ear surgery under general anesthesia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20101211005362N27

Enrollment

165

Registered

2022-01-22

Start date

2021-11-22

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post operative nausea and vomiting. Nausea after surgery

Interventions

Intervention 1: Intervention group: they receive 0/1 mg per kg ondansetron in 10 cc normal saline in 10 minute. Intervention 2: Control group: 10 cc normal saline in 10 minute. Intervention 3: Interv

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: People who willingly want to participate in the study ASA class 1,2 People between the ages of 18 and 65 y/o No motion sickness or Parkinson's disease

Exclusion criteria

Exclusion criteria: Heart, liver, kidney failure Previous sensitivity to the drugs used in the study Obese patients (BMI more than 30) Patients with mental retardation Patients who have taken antiemetic before operation. Any change in anesthesia Patient death during surgery Surgeries that cause severe nausea and vomiting, such as surgery on the labyrinth (otosclerosis, cholesteatoma with fistula, etc.)

Design outcomes

Primary

Measure	Time frame
Mean severity of post operative nausea. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: Visual analog scale.;Frequency of post operative vomiting. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: According to percentage.;The average dose of antiemetic used. Timepoint: In the recovery and the first 24 hours after surgery. Method of measurement: Dose of drug used.;The average of first time, antiemetic needed. Timepoint: In the recovery and the first 24 hours after surgery. Method of measurement: Time that drug used.;The first time that the fluid diet tolerated. Timepoint: The first 24 hours after surgery. Method of measurement: Time the diet tolerated.;The average time took to tolerate solid diet. Timepoint: The first 48 hours after surgery. Method of measurement: Time the diet tolerated.;Mean patient satisfaction score. Timepoint: The first 24 hours after surgery. Method of measurement: Visual analog scale.	—

Measure

Time frame

Mean severity of post operative nausea. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: Visual analog scale.;Frequency of post operative vomiting. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: According to percentage.;The average dose of antiemetic used. Timepoint: In the recovery and the first 24 hours after surgery. Method of measurement: Dose of drug used.;The average of first time, antiemetic needed. Timepoint: In the recovery and the first 24 hours after surgery. Method of measurement: Time that drug used.;The first time that the fluid diet tolerated. Timepoint: The first 24 hours after surgery. Method of measurement: Time the diet tolerated.;The average time took to tolerate solid diet. Timepoint: The first 48 hours after surgery. Method of measurement: Time the diet tolerated.;Mean patient satisfaction score. Timepoint: The first 24 hours after surgery. Method of measurement: Visual analog scale.

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Secondary

Measure	Time frame
Duration of anesthesia of patient. Timepoint: During the operation and 24 hour after that. Method of measurement: Minute.;Duration of surgery of patient. Timepoint: During the operation. Method of measurement: Minute.;Average length of stay in recovery. Timepoint: During the presence in recovery. Method of measurement: Modified aldrete score.;Average of pain intensity. Timepoint: The first 24 hour after surgery. Method of measurement: visual analog scale.;Average time of extubation. Timepoint: After surgery. Method of measurement: Minute.	—

Measure

Time frame

Duration of anesthesia of patient. Timepoint: During the operation and 24 hour after that. Method of measurement: Minute.;Duration of surgery of patient. Timepoint: During the operation. Method of measurement: Minute.;Average length of stay in recovery. Timepoint: During the presence in recovery. Method of measurement: Modified aldrete score.;Average of pain intensity. Timepoint: The first 24 hour after surgery. Method of measurement: visual analog scale.;Average time of extubation. Timepoint: After surgery. Method of measurement: Minute.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammadreza Safavi Homami

Esfahan University of Medical Sciences

safavi@med.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

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