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The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. This study aims to investigate the following aspects: the incidence of adverse respiratory and circulatory events requiring medical intervention following the administration of dexmedetomidine nasal spray for pre-anesthetic sedation, its sedative efficacy and onset time, and its impact on the quality of post-anesthesia recovery and the occurrence of postoperative delirium. Researchers will compare dexmedetomidine hydrochloride nasal spray to a placebo (a look-alike substance that contains no drug) to see the incidence and severity of adverse events following administration. Participants will receive either dexmedetomidine nasal spray or a placebo 45 minutes before anesthesia induction. The blinded assessor will continuously monitor and record vital signs, adverse events, and the level of sedation. More importantly, observations and records should be made for respiratory and circulatory events that require medical intervention. A follow-up assessment will be conducted within three days after the operation to evaluate the incidence of postoperative delirium and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(LD): Dexmedetomidine hydrochloride nasal spray 50μg, and placebo nasal spray 50μg | Experimental |
| |
| Group 2(HD): Dexmedetomidine hydrochloride nasal spray 100μg | Experimental |
| |
| Group 3(C): Placebo nasal spray 100μg | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine hydrochloride nasal spray | Drug | Group 1 (LD) was administered 50 μg of dexmedetomidine hydrochloride nasal spray and 50 μg of placebo nasal spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events in the circulatory and respiratory system requiring medical intervention | 45 minutes after administration, before the induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Ramsay score | The Ramsay Sedation Scale is a widely used tool to assess the level of sedation in patients; a higher level indicates a stronger sedative effect. Level 1 : Anxiety, with agitation or restlessness. Level 2 : Calm and cooperative, with orientation to time and place. Level 3 : Responds to commands, but with delayed or slurred speech. Level 4 : Sleepy, but easily arousable to voice. Level 5 : Sleepy, with a slow response to voice. Level 6 : Deeply sedated, with no response to voice or light stimulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Li | Contact | +86 13668169590 | lipengmazui@163.com | |
| Yujing Liu | Contact | +86 13648150630 | 1278700334@qq.com |
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| Placebo | Drug | Group 3 (C) was administered 100 μg of placebo nasal spray |
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| Dexmedetomidine hydrochloride nasal spray | Drug | Group 2 (HD) was administered 100 μg of dexmedetomidine hydrochloride nasal spray |
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| 45 minutes after administration, before the induction of anesthesia |
| The time from the end of the surgery to the first postoperative Aldrete score ≥ 9 | Day 1 |
| The incidence of circulatory and respiratory adverse events that require medical intervention as determined by researchers from the end of surgery to the exit of PACU | From the end of surgery to the exit of PACU |
| Incidence of POD | Within 72 hours after the surgery was completed |
| Postoperative patient and anesthesiologist satisfaction score | The patients and the anesthesiologists rated the satisfaction of this anesthesia on a scale of 1 to 10. The higher the score, the higher the level of satisfaction. | Within 72 hours after the surgery was completed |