To compare three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery

A comparative clinical trial comparing three maintenance doses of Dexmedetomidine for intravenous sedation in third molar extraction surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034551

Enrollment

Registered

2021-07-02

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: K011- Impacted teeth

Interventions

Intervention1: compare 3 maintenance doses of dexmedetomidine: To determine the ideal maintenence dose of dexmedetomidine suitable for sedation with minimal side effects and early discharge from the O

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 patient Patient requiring 3rd molar extraction surgery under LA Patient willing for intravenous sedation during the procedure

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
1. Amnesia 2. Surgeon satisfaction score 3. Patient satisfaction score 4. Duration of analgesia 5. Requirement of rescue sedation 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 2. Surgeon satisfaction score: noted post operatively 3. Patient satisfaction score: noted post operatively 4. Duration of Analgesia- noted postoperatively 5. Requirement of rescue sedation with 1 mg intravenous Midazolam if Ramsay sedation score is 1 during the procedure 6. Any other side effects in the intraoperative or postoperative period will be noted	—

Measure

Time frame

1. Amnesia 2. Surgeon satisfaction score 3. Patient satisfaction score 4. Duration of analgesia 5. Requirement of rescue sedation 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 2. Surgeon satisfaction score: noted post operatively 3. Patient satisfaction score: noted post operatively 4. Duration of Analgesia- noted postoperatively 5. Requirement of rescue sedation with 1 mg intravenous Midazolam if Ramsay sedation score is 1 during the procedure 6. Any other side effects in the intraoperative or postoperative period will be noted

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Primary

Measure	Time frame
Primary objectives: to compare the following parameters: 1. Sedation scores 2. Pain scores 3. Hemodynamic and respiratory effects 4. Time of discharge of patient Secondary objectives: to compare the following parameters: 1. Amnesia 2. Surgeon satisfaction score 3. Patient satisfaction score 4. Duration of analgesia 5. Requirement of rescue sedation 6. Any other side effects noted during the procedure Timepoint: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2 and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.	—

Measure

Time frame

Primary objectives: to compare the following parameters: 1. Sedation scores 2. Pain scores 3. Hemodynamic and respiratory effects 4. Time of discharge of patient Secondary objectives: to compare the following parameters: 1. Amnesia 2. Surgeon satisfaction score 3. Patient satisfaction score 4. Duration of analgesia 5. Requirement of rescue sedation 6. Any other side effects noted during the procedure Timepoint: Parameters like heart rate , Systolic and diastolic BP, Respiratory rate ,SPO2 and ECG shall be noted pre operatively and then every 5 minutes till Till PARSAP score of greater than equal to 18 is achieved. VAS score is calculated from starting the drug infusion till the end of the procedure for every 5 minutes. PARSAP score is calculated after the procedure is complete till it is greater than equal to 18 for every 10 minutes.

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Countries

India

Contacts

Public ContactDr Hemant Batra

Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital

hemant_batra69@yahoo.com9814555550

Outcome results

None listed

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