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Remimazolam in the Extraction of Impacted Wisdom Teeth

Primary Purpose

Dental Anxiety, Sedation Complication, Anterograde Amnesia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remimazolam besylate
Midazolam
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have mandibular impacted wisdom teeth need to be extracted;
  2. Body mass index (BMI) between 18.5 and 30 kg/m2;
  3. 18-60 years old;
  4. The American Society of Anesthesiologists (ASA) is classified as grade I ~ II;
  5. Voluntary dental comfort care;
  6. Voluntary participation and signed informed consent.

Exclusion Criteria:

  1. Suffer from respiratory tract infection, asthma attack and persistent state;
  2. Have contraindications to anesthesia or previous abnormal surgical anesthesia recovery history;
  3. Have severe cardiopulmonary diseases (such as severe ECG abnormalities and cardiopulmonary insufficiency);
  4. Preoperative blood pressure > 160/100mmHg or diastolic blood pressure > 100mmHg, or blood pressure < 90/60mmHg;
  5. Have serious intraoperative complications due to potential or combined diseases (such as family history of malignant hyperthermia);
  6. Have neuromuscular diseases, mental diseases or unable to communicate effectively and do not cooperate;
  7. Suspected of abusing narcotic analgesics or sedatives;
  8. Known allergy to benzodiazepines or contraindication;
  9. Participated in other drug trials within six months.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam Group

Midazolam Group

Arm Description

Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.

Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.

Outcomes

Primary Outcome Measures

Recovery time of complete alertness
Calculated from the cessation of sedative injection with micro injection pump, the patients were scored with the modified observer's assessment of alertness/sedation scale (MOAA/S) every 1 minute, and the first minute with MOAA/S score = 5 for 3 consecutive times. MOAA/S score: Range from 5(Awake) to 1(Unresponsive).

Secondary Outcome Measures

Anterograde amnesia duration
Patients were given 3 different cards(including animals, fruits, vegetables, vehicles）at 0， 15，30，60 minutes after complete alertness（described at primary outcome). They were asked to recall them immediately and delayed(approximately 5 minutes after Immediate memory).
Interruption reasons during operation
It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation.

Full Information

First Posted
April 10, 2022
Last Updated
April 5, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05350085
Brief Title
Remimazolam in the Extraction of Impacted Wisdom Teeth
Official Title
A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Benzodiazepines, represented by midazolam, are often used for sedation in outpatient surgery in dentistry. However, midazolam has the problems of slow consciousness recovery and long recovery time, which brings trouble to the patients. Remimazolam is a new type of ultra short acting sedative anesthetic. Compared with other similar products, remimazolam has faster effect, rapid metabolism and has no accumulation, which may mean that compared with midazolam, remimazolam has a better clinical application prospect in dental outpatient surgery.
Detailed Description
The patients were randomly divided into midazolam group and remimazolam group. The onset time of drugs, postoperative recovery time, vital signs, anterograde amnesia and other complications were observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Sedation Complication, Anterograde Amnesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam Group
Arm Type
Experimental
Arm Description
Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
Arm Title
Midazolam Group
Arm Type
Active Comparator
Arm Description
Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Intervention Description
① initial dose: use a micro injection pump to pump remimazolam at the rate of 50mg/h, and observe for 4 ~ 8 minutes until Ramsay Sedation grade III，then start dental operation ; ② Maintenance dose: maintain the pump speed at 5 ~ 10mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
① initial dose: use a micro injection pump to pump remazolam at the rate of 30mg/h, and observe for 4 ~ 8 minutes until Ramsay Sedation grade III，then start dental operation; ② Maintenance dose: maintain the pump speed at 3 ~ 6mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.
Primary Outcome Measure Information:
Title
Recovery time of complete alertness
Description
Calculated from the cessation of sedative injection with micro injection pump, the patients were scored with the modified observer's assessment of alertness/sedation scale (MOAA/S) every 1 minute, and the first minute with MOAA/S score = 5 for 3 consecutive times. MOAA/S score: Range from 5(Awake) to 1(Unresponsive).
Time Frame
During treatment in hospital, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Anterograde amnesia duration
Description
Patients were given 3 different cards(including animals, fruits, vegetables, vehicles）at 0， 15，30，60 minutes after complete alertness（described at primary outcome). They were asked to recall them immediately and delayed(approximately 5 minutes after Immediate memory).
Time Frame
During treatment in hospital, an expected average of 2 hours
Title
Interruption reasons during operation
Description
It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation.
Time Frame
During treatment in hospital, an expected average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consenting patients will be eligible if they: Have mandibular impacted wisdom teeth that need to be extracted; Have a body mass index (BMI) between 18.5 and 30 kg/m2; Are aged between 18 and 60 years; Have American Society of Anesthesiology (ASA) classification grade of I-II; Have Modified Dental Anxiety Scale (MDAS) score > 15; and Volunteered to accept intravenous sedation. Exclusion Criteria: Patients will be ineligible if they: Are pregnant; Experience respiratory infections, asthma attack or persistent state; Have contraindications to anaesthesia or a previous abnormal surgical anaesthesia recovery history; Have severe cardiopulmonary insufficiency; Have preoperative blood pressure > 160/100 mmHg or diastolic blood pressure > 100 mmHg, or blood pressure < 90/60 mmHg; Have a neuromuscular or mental disorder that renders them unable to communicate or cooperate effectively or sign informed consent; Are suspected of abusing narcotic analgesics or sedatives; Have a known allergy or contraindication to benzodiazepines; or Have participated in other drug trials within 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijian Pei, MD
Phone
18612672127
Email
hazelbeijing@vip.163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijian Pei, MD
Phone
18612672127
Email
hazelbeijing@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal.

Learn more about this trial

Remimazolam in the Extraction of Impacted Wisdom Teeth

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