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Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | dexmedetomidine 1μg•kg-1 |
|
| midazolam | Active Comparator | midazolam 0.03 mg•kg-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative heart rate response | Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation | Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours. | |
| Adjuvant anesthesia effect | Target-controlled infusion concentrations of propofol and remifentanyl at intubation, start and completion of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure | Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangcai Ruan, MD, PhD. | Contact | +8620-81048306 | xc_ruan@hotmail.com | |
| Huan Yang, MD. | Contact | +8620-81048310 | yanghuan0401@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcai Ruan, MD, PhD. | Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510180 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23878437 | Result | Jayaraman L, Sinha A, Punhani D. A comparative study to evaluate the effect of intranasal dexmedetomidine versus oral alprazolam as a premedication agent in morbidly obese patients undergoing bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):179-82. doi: 10.4103/0970-9185.111680. | |
| 23162393 | Result |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D013812 | Therapeutics |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Midazolam |
|
|
| Participants will be monitored for the duration of anesthesia, an expected average of half an hour. |
| Patient's over-all satisfaction | On discharge from recovery patients were asked to rate their satisfaction with the anaesthesia and the surgery that they had received as; highly satisfactory, acceptable, or unacceptable. | On leaving the post-care unite, an expected average of 2 min. |
| Gupta K, Jain M, Gupta PK, Rastogi B, Saxena SK, Manngo A. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial. Saudi J Anaesth. 2012 Jul;6(3):219-23. doi: 10.4103/1658-354X.101211. |
| 18285392 | Result | Mowafi HA, Aldossary N, Ismail SA, Alqahtani J. Effect of dexmedetomidine premedication on the intraocular pressure changes after succinylcholine and intubation. Br J Anaesth. 2008 Apr;100(4):485-9. doi: 10.1093/bja/aen020. Epub 2008 Feb 19. |
| 11350323 | Result | Peden CJ, Cloote AH, Stratford N, Prys-Roberts C. The effect of intravenous dexmedetomidine premedication on the dose requirement of propofol to induce loss of consciousness in patients receiving alfentanil. Anaesthesia. 2001 May;56(5):408-13. doi: 10.1046/j.1365-2044.2001.01553.x. |
| 9135361 | Result | Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400. |
| 7943770 | Result | Erkola O, Korttila K, Aho M, Haasio J, Aantaa R, Kallio A. Comparison of intramuscular dexmedetomidine and midazolam premedication for elective abdominal hysterectomy. Anesth Analg. 1994 Oct;79(4):646-53. doi: 10.1213/00000539-199410000-00006. |
| 7802178 | Result | Virkkila M, Ali-Melkkila T, Kanto J, Turunen J, Scheinin H. Dexmedetomidine as intramuscular premedication for day-case cataract surgery. A comparative study of dexmedetomidine, midazolam and placebo. Anaesthesia. 1994 Oct;49(10):853-8. doi: 10.1111/j.1365-2044.1994.tb04257.x. |
| 25529851 | Derived | Sun Y, Liu C, Zhang Y, Luo B, She S, Xu L, Ruan X. Low-dose intramuscular dexmedetomidine as premedication: a randomized controlled trial. Med Sci Monit. 2014 Dec 18;20:2714-9. doi: 10.12659/MSM.891051. |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |