Trial · NCT02108171
Intranasal Dexmedetomidine Premedication
NCT02108171, Not applicable, Completed, Guangzhou First People's Hospital; results first posted 2016-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intranasal Dexmedetomidine Premedication. Trials, record NCT02108171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02108171
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Dexmedetomidine Premedication
- NCT number
- NCT02108171
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 81 participants, actual
- Lead sponsor
- Guangzhou First People's Hospital
- Conditions
- Benign Neoplasm of Vocal Fold - Glottis
- Interventions
- Dexmedetomidine, placebo
- First posted
- 2014-04-09
- Last updated
- 2016-03-14
- Results first posted
- 2016-03-14
Source ClinicalTrials.gov
Registered outcomes78
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extubation Time After Intranasal Dexmedetomidine Premedication | 1 days | The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration |
| Secondary | Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 days | Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine. Modified Observer's Assessment of Alertness/Sedation Scale: 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus. |
| Secondary | Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study. |
| Secondary | Number of Participants With Anxiety Score >2 | 1 day | satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction. Anxiety score \>2 was considered to be better for the patient. |
| Secondary | Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | 4-point anxiety score: 1. = combative 2. = anxious 3. = calm 4. = amiable. Anxiety score \>2 was considered to be better for the preoperative patients. |
| Secondary | Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine. |
| Secondary | Number of Participants With Satisfaction Score <2 | 1 day | Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU). Satisfaction score \<2 was considered to be better for the patient |
| Secondary | Perioperative Bradycardia Episodes | 1 day | Bradycardia was defined as heart rate (HR) \<45 bpm for more than 10 s. |
| Secondary | Perioperative Tachycardia Episodes | 1 day | Tachycardia was defined as heart rate (HR) \>100 bpm for more than 10 s. |
| Secondary | Perioperative Hypotension Episodes | 1 day | Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min. |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 registered outcomesOutcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Extubation Time After Intranasal Dexmedetomidine Premedication | 1 days | min | MEAN | |
| SECONDARY | Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 days | units on a scale | MEDIAN | |
| SECONDARY | Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | bpm | MEAN | |
| OTHER_PRE_SPECIFIED | Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo | 1 day | kg | NUMBER | |
| OTHER_PRE_SPECIFIED | Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine | 1 day | kg | NUMBER | |
| OTHER_PRE_SPECIFIED | Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo | 1 day | cm | NUMBER | |
| OTHER_PRE_SPECIFIED | Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine | 1 day | cm | NUMBER | |
| OTHER_PRE_SPECIFIED | Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine | 1 day | participant | NUMBER | |
| OTHER_PRE_SPECIFIED | Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo | 1 day | minutes | NUMBER |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 outcomesResults by group2,550
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extubation Time After Intranasal Dexmedetomidine Premedication | Dexmedetomidine | Extubation time | 18.58 | Standard Deviation 7.376 | min |
| Extubation Time After Intranasal Dexmedetomidine Premedication | Placebo | Extubation time | 17.16 | Standard Deviation 7.142 | min |
| Extubation Time After Intranasal Dexmedetomidine Premedication | Dexmedetomidine | consciousness time | 16.21 | Standard Deviation 6.278 | min |
| Extubation Time After Intranasal Dexmedetomidine Premedication | Placebo | consciousness time | 14.74 | Standard Deviation 6.353 | min |
| Extubation Time After Intranasal Dexmedetomidine Premedication | Dexmedetomidine | adequate ventilation time | 8.24 | Standard Deviation 3.183 | min |
| Extubation Time After Intranasal Dexmedetomidine Premedication | Placebo | adequate ventilation time | 7.87 | Standard Deviation 2.648 | min |
| Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | Dexmedetomidine | Before intranasal drugs | 6 | Inter-Quartile Range 6 to 6 | units on a scale |
| Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | Placebo | Before intranasal drugs | 6 | Inter-Quartile Range 6 to 6 | units on a scale |
| Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | Dexmedetomidine | Pre-induction | 4 | Inter-Quartile Range 4 to 5 | units on a scale |
| Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | Placebo | Pre-induction | 6 | Inter-Quartile Range 5 to 6 | units on a scale |
1 to 10 of 2,550Source ClinicalTrials.gov
See all 2,550 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine | 40 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | Dexmedetomidine | 40 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Episodes of hypertension | Cardiac disorders | Dexmedetomidine | 9 | 40 | 9 |
| other | Episodes of hypertension | Cardiac disorders | Placebo | 16 | 41 | 16 |
| other | Episodes of hypotension | Cardiac disorders | Dexmedetomidine | 1 | 40 | 1 |
| other | Episodes of hypotension | Cardiac disorders | Placebo | 0 | 41 | 0 |
| other | Episodes of tachycardia | Cardiac disorders | Dexmedetomidine | 7 | 40 | 7 |
| other | Episodes of tachycardia | Cardiac disorders | Placebo | 20 | 41 | 20 |
| other | Episodes of bradycardia | Cardiac disorders | Dexmedetomidine | 8 | 40 | 8 |
| other | Episodes of bradycardia | Cardiac disorders | Placebo | 10 | 41 | 10 |
| other | Episodes of Respiratory depression | Reproductive system and breast disorders | Dexmedetomidine | 5 | 40 | 5 |
| other | Episodes of Respiratory depression | Reproductive system and breast disorders | Placebo | 11 | 41 | 11 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dexmedetomidine | 20 | 40 |
| Total, other adverse events | Placebo | 34 | 41 |
| Total, serious adverse events | Dexmedetomidine | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexmedetomidine vs Placebo: Patients With Postoperative Vomiting in Two Groups | Trial comparisons |
| Dexmedetomidine vs Placebo: Patients With Postoperative Shivering in Two Groups | Trial comparisons |
| Dexmedetomidine vs Placebo: Patients With Intra-operative Awareness in Two Groups | Trial comparisons |
| Dexmedetomidine vs Placebo: Patients With Postoperative Nausea in Two Groups | Trial comparisons |
| Dexmedetomidine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02108171
GET https://conductscience.org/api/trials/v1/NCT02108171/registered?page=2