Evidence map›Paper›PMID 41978698›Full record

Trial reportDrug design, development and therapy2026

A Novel Standardized Dexmedetomidine Nasal Spray Formulation for Procedural Sedation During Venous Port Implantation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Jie Tong, Mengping Wei, Zhixiang Ye, Huayuan Gao, Weifeng Hong, Peiling Cai, Wenjun Li, Jie Wang, Xiushi Zhou, Chao Liang and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jie Tong *Department of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Mengping Wei *Department of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Zhixiang Ye *Department of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Huayuan GaoDepartment of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Weifeng HongDepartment of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Peiling CaiDepartment of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Wenjun LiDepartment of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Jie WangDepartment of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Xiushi ZhouDepartment of Population Health Sciences, Duke University School of Medicine, Durham, NC, 27701, USA.
Chao Liang *Department of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People's Republic of China.
Zhiyao Wang *Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.ORCID 0000-0002-6514-0333

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Noninvasive sedative approaches are increasingly valued in ambulatory anesthesia. The aim of this study was to evaluate the efficacy and safety of the novel standardized dexmedetomidine nasal spray for procedural sedation in adult patients undergoing port implantation under local anesthesia. Methods: Eighty-two patients undergoing port implantation under local anesthesia were enrolled in this study. The patients were randomly allocated to receive nasal spray with 100μg dexmedetomidine or placebo with saline, 30 min prior to the procedure. The primary outcome was the postoperative anesthesia satisfaction assessed using Iowa Satisfaction with Anesthesia Scale (ISAS; 11-item mean score, -3 to +3). The secondary outcomes included the Ramsay sedation scale (RSS), visual analog scale (VAS), postoperative sleep quality, hemodynamic changes, and the incidence of adverse events. Results: Compared with placebo, dexmedetomidine significantly improved satisfaction with procedure (ISAS median [IQR] was 2.7 [2.5-2.8] vs 2.1 [1.8-2.4]; P<0.001), indicating a clinically relevant improvement in patient experience during outpatient port implantation under local anesthesia, and postoperative sleep quality (4.4±0.8 vs 3.1±0.8, P<0.001) during the first postoperative night. The incidence of adverse events and other secondary outcomes were comparable between the two groups. Conclusion: A standardized dexmedetomidine nasal spray provided reliable, well-tolerated sedation, enhanced postoperative comfort, and improved postoperative sleep quality in adults undergoing minor procedures under local anesthesia. These findings support its feasibility as a noninvasive option for outpatient procedural sedation.

Indexed as

DexmedetomidineHypnotics and SedativesAdministration, IntranasalAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedNasal SpraysPatient SatisfactionDexmedetomidineHypnotics and SedativesNasal Spraysadministrationambulatory surgical proceduresconscious sedationdexmedetomidineintranasalpatient satisfactionvascular access devices

Identifiers

PMID41978698
PMCPMC13070333

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.