PMID- 33721199 OWN - NLM STAT- MEDLINE DCOM- 20210622 LR - 20210731 IS - 1496-8975 (Electronic) IS - 0832-610X (Linking) VI - 68 IP - 7 DP - 2021 Jul TI - Intranasal administration of 40 and 80 units of insulin does not cause hypoglycemia during cardiac surgery: a randomized controlled trial. PG - 991-999 LID - 10.1007/s12630-021-01969-5 [doi] AB - PURPOSE: Intranasal insulin administration may improve cognitive function in patients with dementia and may prevent cognitive problems after surgery. Although the metabolic effects of intranasal insulin in non-surgical patients have been studied, its influence on glucose concentration during surgery is unknown. METHODS: We conducted a randomized, double-blind, placebo-contolled trial in patients scheduled for elective cardiac surgery. Patients with type 2 diabetes mellitus (T2DM) and non-T2DM patients were randomly allocated to one of three groups (normal saline, 40 international units [IU] of intranasal insulin, and 80 IU intranasal insulin). Insulin was given after the induction of general anesthesia. Glucose and plasma insulin concentrations were measured in ten-minute intervals during the first hour and every 30 min thereafter. The primary outcome was the change in glucose concentration 30 min after intranasal insulin administration. RESULTS: A total of 115 patients were studied, 43 of whom had T2DM. In non-T2DM patients, 40 IU intranasal insulin did not affect glucose concentration, while 80 IU intranasal insulin led to a statistically significant but not clinically important decrease in blood glucose levels (mean difference, 0.4 mMol.L(-1); 95% confidence interval, 0.1 to 0.7). In T2DM patients, neither 40 IU nor 80 IU of insulin affected glucose concentration. No hypoglycemia (< 4.0 mMol.L(-1)) was observed after intranasal insulin administration in any patients. In non-T2DM patients, changes in plasma insulin were similar in the three groups. In T2DM patients, there was an increase in plasma insulin concentrations ten minutes after administration of 80 IU of intranasal insulin compared with saline. CONCLUSIONS: In patients with and without T2DM undergoing elective cardiac surgery, intranasal insulin administration at doses as high as 80 IU did not cause clinically important hypoglycemia. TRIAL REGISTRATION: www.ClinicalTrials.gov (NCT02729064); registered 5 April 2016. FAU - Roque, Patricia AU - Roque P AD - School of Human Nutrition, McGill University, Ste-Anne-de-Bellevue, Montreal, QC, Canada. FAU - Nakadate, Yosuke AU - Nakadate Y AUID- ORCID: 0000-0002-5095-2072 AD - Department of Anesthesiology, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan. ynakadate@yamanashi.ac.jp. FAU - Sato, Hiroaki AU - Sato H AD - Department of Anesthesia, McGill University Health Centre Glen Site, Royal Victoria Hospital, Montreal, QC, Canada. FAU - Sato, Tamaki AU - Sato T AD - Department of Anesthesia, McGill University Health Centre Glen Site, Royal Victoria Hospital, Montreal, QC, Canada. FAU - Wykes, Linda AU - Wykes L AD - School of Human Nutrition, McGill University, Ste-Anne-de-Bellevue, Montreal, QC, Canada. FAU - Kawakami, Akiko AU - Kawakami A AD - Department of Anesthesia, McGill University Health Centre Glen Site, Royal Victoria Hospital, Montreal, QC, Canada. FAU - Yokomichi, Hiroshi AU - Yokomichi H AD - Department of Health science, University of Yamanashi, Shimokato, Chuo, Yamanashi, Japan. FAU - Matsukawa, Takashi AU - Matsukawa T AD - Department of Health science, University of Yamanashi, Shimokato, Chuo, Yamanashi, Japan. FAU - Schricker, Thomas AU - Schricker T AD - Department of Anesthesia, McGill University Health Centre Glen Site, Royal Victoria Hospital, Montreal, QC, Canada. LA - eng SI - ClinicalTrials.gov/NCT02729064 PT - Journal Article PT - Randomized Controlled Trial TT - L'administration intranasale de 40 et 80 unites d'insuline ne provoque pas d'hypoglycemie pendant une chirurgie cardiaque : une etude randomisee controlee. DEP - 20210315 PL - United States TA - Can J Anaesth JT - Canadian journal of anaesthesia = Journal canadien d'anesthesie JID - 8701709 RN - 0 (Blood Glucose) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) SB - IM MH - Administration, Intranasal MH - Blood Glucose MH - *Cardiac Surgical Procedures MH - *Diabetes Mellitus, Type 2/drug therapy MH - Double-Blind Method MH - Humans MH - *Hypoglycemia/chemically induced/prevention & control MH - Hypoglycemic Agents MH - Insulin/therapeutic use OTO - NOTNLM OT - cardiac surgery OT - delirium OT - glycemia OT - intranasal insulin EDAT- 2021/03/16 06:00 MHDA- 2021/06/23 06:00 CRDT- 2021/03/15 17:37 PHST- 2020/08/06 00:00 [received] PHST- 2021/01/02 00:00 [accepted] PHST- 2020/12/30 00:00 [revised] PHST- 2021/03/16 06:00 [pubmed] PHST- 2021/06/23 06:00 [medline] PHST- 2021/03/15 17:37 [entrez] AID - 10.1007/s12630-021-01969-5 [pii] AID - 10.1007/s12630-021-01969-5 [doi] PST - ppublish SO - Can J Anaesth. 2021 Jul;68(7):991-999. doi: 10.1007/s12630-021-01969-5. Epub 2021 Mar 15.