ArticleIndian journal of anaesthesia2024
Efficacy and safety of a generic remifentanil formulation versus fentanyl and Ultiva during general anaesthesia: A phase III, prospective, multi-centric, observer-blind, randomised controlled trial.
Article in Indian journal of anaesthesia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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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.
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.
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Who cites it
2 citing papers in PubMed.
- Hypothesis reporting in randomised controlled trials: A critical appraisal of IJA 2024 publications.Indian journal of anaesthesia · 2025Article
- Remifentanil reduces post-induction hypotension compared to fentanyl in thoracoscopic esophagectomy: a retrospective cohort study.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and Aims: Remifentanil and fentanyl are potent opioid analgesics commonly used during surgery due to their distinct pharmacological profiles. This study aimed to compare the efficacy and safety of a generic remifentanil (test drug) with fentanyl and Ultiva (innovator formulation) during general anaesthesia in the Indian population. Methods: This phase III, multi-centre (n = 13), randomised, three-arm, comparative study was conducted from 24 November 2021 to 31 March 2022. Eligible subjects scheduled for elective therapeutic and diagnostic surgical procedures (n = 314) were randomised into generic remifentanil, Ultiva, and fentanyl groups. An independent anaesthetist blinded to treatment allocation assessed efficacy and safety parameters. The primary efficacy endpoint was haemodynamic response during specific activities (endotracheal intubation, skin incision, skin closure, and extubation). Results: The study groups exhibited no significant differences in demographic and baseline characteristics. Heart rate was similar between the remifentanil and Ultiva groups measured during laryngeal intubation, skin incision, skin closure, and extubation ( Conclusion: Our study's findings demonstrated that generic remifentanil is non-inferior to fentanyl and equivalent to Ultiva for general anaesthesia in Indian patients undergoing various surgical and diagnostic procedures. Remifentanil offers advantages in terms of optimum haemodynamic stability, fast equilibrating analgesia, and rapid emergence from sedation, making it a suitable alternative to fentanyl.
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