Evidence map›Paper›PMID 39379858›Full record

Trial reportBMC anesthesiology2024

Comparison of hypotension between propofol and remimazolam-propofol combinations sedation for day-surgery hysteroscopy: a prospective, randomized, controlled trial.

Hua Tan, Aifei Lou, Jianer Wu, Xinzhong Chen, Xiaowei Qian

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in BMC anesthesiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Trial
  4. Observational
  5. Article
  6. Article
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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

5 authors.

Hua TanDepartment of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
Aifei LouDepartment of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
Jianer WuDepartment of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
Xinzhong ChenDepartment of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China. chenxinz@zju.edu.cn.
Xiaowei QianDepartment of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China. qianxw@zju.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA combination of remimazolam and propofol could produce more stable sedation. A good medication regimen should consider not only efficacy but also safety, especially hypotension. The aim of the current study was to compare the incidence and amount of hypotension by propofol versus remimazolam-propofol combinations in day-surgery hysteroscopy.

methodsPatients were randomly assigned to receive either propofol (Group P, n = 125) or remimazolam-propofol combinations (Group RP, n = 125) at a 1:1 ratio. Intravenous injection of sufentanil 0.1ug/kg were administered before sedative medication. In group P, a bolus of 2.5 mg/kg propofol was administered. In group RP, intravenous anesthesia was commenced with 0.125 mg/kg remimazolam and 1 mg/kg propofol. After loss of consciousness, propofol was maintained at 6 mg/kg/h. The primary outcomes were the incidence and amount of hypotension during surgery. Hypotension was defined as a MAP less than 65mmHg for at least 1 min. The amount of hypotension was assessed by time-weighted average intraoperative MAP under a threshold of 65 mmHg. The secondary outcomes were various anesthesia related parameters and some adverse events.

resultsIn group P, 25 patients (20.0%) experienced hypotension during hysteroscopy compared with 9 patients (7.2%) in group RP, for a difference of 12.8% (RR 2.778, 95%CI [1.352-5.709]). The combination of remimazolam and propofol resulted in significantly lower TWA (Time Weighted Average) threshold 0.14 (0.10-0.56) mmHg in group RP compared to 0.31 (0.15-0.67) mmHg in group P. The total dose of propofol was nearly double in group P compared to group RP. A significantly higher frequency of injection pain and low oxygen saturation was observed in the group P than that of the group RP. Hiccup was observed only in group RP. The incidences of body movement, bradycardia and vomiting were no significant difference between groups.

conclusionThe incidence and amount of hypotension by remimazolam-propofol combinations was significantly less than that by propofol sedation in day-surgery hysteroscopy. The optimization of medication regimen would attenuate the harm of hypotension and contribute to patients' rapid recovery in day surgery.

trial registrationChinese Clinical Trial Registry, ChiCTR2400079888 (date: 15/01/2024).

Indexed as

Ambulatory Surgical ProceduresHypnotics and SedativesHypotensionHysteroscopyPropofolAdultAnesthetics, IntravenousBenzodiazepinesFemaleHumansMiddle AgedProspective StudiesAnesthetics, IntravenousBenzodiazepinesHypnotics and SedativesPropofolremimazolamDay surgeryHypotensionHysteroscopyIntravenous sedationPropofolRemimazolam

Identifiers

PMID39379858
PMCPMC11460140

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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.