Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels
Parole chiave
Astratto
Descrizione
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adults patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded.
Date
| Ultimo verificato: | 05/31/2019 |
| Primo inviato: | 12/29/2018 |
| Iscrizione stimata inviata: | 01/16/2019 |
| Primo pubblicato: | 01/17/2019 |
| Ultimo aggiornamento inviato: | 06/20/2019 |
| Ultimo aggiornamento pubblicato: | 06/24/2019 |
| Data di inizio effettiva dello studio: | 02/28/2013 |
| Data di completamento primaria stimata: | 01/31/2014 |
| Data stimata di completamento dello studio: | 01/31/2014 |
Condizione o malattia
Intervento / trattamento
Drug: Dexmedetomidine
Drug: 0.9% Sodium-chloride
Drug: Fentanyl
Drug: Morphine Sulfate
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Experimental: Dexmedetomidine After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/min until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. | Drug: Dexmedetomidine A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. |
| Placebo Comparator: 0.9% Sodium-chloride After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. | Drug: 0.9% Sodium-chloride The same dose used in the dexmedetomidine group (bolus and infusion). |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: - Obese patient (BMI>30) - American Society of Anesthesiologists grades II or III - Diagnosis of impaired glucose tolerance - Undergoing sleeve gastrectomy Exclusion Criteria: - Baseline glucose > 200mg/dl - Diagnosis of Diabetes - Under corticosteroids treatment - Oral hypoglycemic medication within 7 days previous surgery - Use of insulin within 24h previous surgery - Allergy to any drug used in the study |
Risultato
Misure di esito primarie
1. Change of baseline glucose levels within the first 12 postoperative hours. [Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine]
2. Change of baseline insulin levels within the first 12 postoperative hours. [Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine]
Misure di esito secondarie
1. Fentanyl consumption. [Intraoperative period.]
2. Morphine consumption in the first 24 postoperative hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).]
3. Pain scores in the first 24 postoperative hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).]
4. Sedation-agitation scores in the first 12 postoperative hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).]
5. Number of patients with postoperative nausea and vomiting in the first 24 postoperative hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).]
