| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000025364 |
| Receipt No. | R000028900 |
| Scientific Title | Clinical study of shivering after general anesthesia (anesthesia method and body temperature) |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2020/05/12 (Ver. 5) |
| Basic information | ||
| Public title | Clinical study of shivering after general anesthesia (anesthesia method and body temperature) | |
| Acronym | Clinical study of shivering after general anesthesia | |
| Scientific Title | Clinical study of shivering after general anesthesia (anesthesia method and body temperature) | |
| Scientific Title:Acronym | Clinical study of shivering after general anesthesia | |
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| Condition | |||
| Condition | jaw deformity | ||
| Classification by specialty |
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| Classification by malignancy | Others | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | We study that anesthesia method and the change of body temperature relate to frequency of shivering. |
| Basic objectives2 | Others |
| Basic objectives -Others | We study prophylaxis of shivering |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | We measure the frequency of shivering after general anesthesia. |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Open -no one is blinded |
| Control | Active |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 6 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | oxygen, laughing gas, sevoflurane, remifentanil | |
| Interventions/Control_2 | oxygen, laughing gas, sevoflurane, remifentanil, fentanil | |
| Interventions/Control_3 | oxygen, laughing gas, sevoflurane, fentanil | |
| Interventions/Control_4 | oxygen, laughing gas, propofol, remifentanil | |
| Interventions/Control_5 | oxygen, laughing gas, propofol, remifentanil, fentanil | |
| Interventions/Control_6 | oxygen, laughing gas, propofol, fentanil | |
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | patients with jaw deformity operated lower jawbone osteotomy | |||
| Key exclusion criteria | patients with jaw deformity operated lower and upper jawbone osteotomy | |||
| Target sample size | 150 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Nihon University School of Dentistry at Matsudo | ||||||
| Division name | Department of Anesthesiology | ||||||
| Zip code | 271-8587 | ||||||
| Address | 2-870-1, Sakaecho-Nishi, Matsudo, Chiba | ||||||
| TEL | 047-360-9440 | ||||||
| ishibashi.hajime@nihon-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Nihon University School of Dentistry at Matsudo | ||||||
| Division name | Department of Anesthesiology | ||||||
| Zip code | 271-8587 | ||||||
| Address | 2-870-1, Sakaecho-Nishi, Matsudo, Chiba | ||||||
| TEL | 047-360-9440 | ||||||
| Homepage URL | |||||||
| ishibashi.hajime@nihon-u.ac.jp | |||||||
| Sponsor | |
| Institute | Nihon University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Nihon University |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Nihon University School of Dentistry at Matsudo |
| Address | 2-870-1, Sakaecho-Nishi, Matsudo, Chiba |
| Tel | 047-360-9440 |
| ishibashi.hajime@nihon-u.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 日本大学松戸歯学部付属病院(千葉県) |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s | ||||||
| Number of participants that the trial has enrolled | 91 | ||||||
| Results | Significant differences in body temperature changes were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000). |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results |
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| Baseline Characteristics | Mean of age and gender ratio (male/female) in each groups were followed: GOS-F group(28.5, 6/11), GOS-R group (25.8, 8/9), GOS-RF group (24.7, 8/6), GOP-F(25.0, 6/6), GOP-R group (26.0, 3/10) and GOP-RF group (25.8, 8/10). |
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| Participant flow | Total patient numbers were 91. Number of GOS-F group, GOS-R group, GOS-RF group, GOP-F group , GOP-R group, and GOP-RF group were 17, 17, 14, 12, 13 and 18. |
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| Adverse events | no |
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| Outcome measures | Based on the occurrence of shivering, the 91 patients were classified into a shivering (S) group (n = 22, 24.2 %) and a non-shivering (NS) group (n = 69, 75.8 %). The RF anesthesia subgroups had 19 patients in the S group and 43 in the NS group; The non-RF anesthesia subgroups had 3 patients in the S group and 26 in the NS group. Thus, shivering was significantly associated with RF anesthesia (p = 0.035). Significant differences in body temperature changes (change from control value) were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000). Significant differences were found between the NS and S groups in forearm minus-fingertip skin temperature gradients (p = 0.008). Forearm minus-fingertip skin temperature gradients differed significantly between the sevoflurane and propofol- groups (p = 0.031). No significant changes in bladder temperature were observed between the NS and S groups (p = 0.239) or between the sevoflurane and propofol groups (p = 0.379). |
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| Recruitment status | Completed | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028900 |