To compare three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery
Phase 4
- Conditions
- Health Condition 1: K011- Impacted teeth
- Registration Number
- CTRI/2021/07/034551
- Lead Sponsor
- Dr Harsimran Kaur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ASA 1 patient
Patient requiring 3rd molar extraction surgery under LA
Patient willing for intravenous sedation during the procedure
Exclusion Criteria
Pregnant females
Lactating mothers.
Patient with history of drug allergy to any drug.
Patient on any medication
History of dental treatment phobia
Abnormal gag reflex
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objectives: to compare the following parameters: <br/ ><br>1.Sedation scores <br/ ><br>2.Pain scores <br/ ><br>3.Hemodynamic and respiratory effects <br/ ><br>4.Time of discharge of patient <br/ ><br> <br/ ><br>Secondary objectives: to compare the following parameters: <br/ ><br> <br/ ><br>1.Amnesia <br/ ><br>2.Surgeon satisfaction score <br/ ><br>3.Patient satisfaction score <br/ ><br>4.Duration of analgesia <br/ ><br>5.Requirement of rescue sedation <br/ ><br>6.Any other side effects noted during the procedure <br/ ><br>Timepoint: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. <br/ ><br>VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. <br/ ><br>PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.
- Secondary Outcome Measures
Name Time Method 1. Amnesia <br/ ><br>2. Surgeon satisfaction score <br/ ><br>3. Patient satisfaction score <br/ ><br>4. Duration of analgesia <br/ ><br>5. Requirement of rescue sedation <br/ ><br>6. Any other side effects noted during the procedureTimepoint: 1. Amnesia- The patient will be asked to recall a pin prick given after 20 minutes of procedure post operatively <br/ ><br>2. Surgeon satisfaction score: noted post operatively <br/ ><br>3. Patient satisfaction score: noted post operatively <br/ ><br>4. Duration of Analgesia- noted postoperatively <br/ ><br>5. Requirement of rescue sedation with 1 mg intravenous Midazolam if Ramsay sedation score is 1 during the procedure <br/ ><br>6. Any other side effects in the intraoperative or postoperative period will be noted