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
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 g...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2024-11-01
|
| Series: | Indian Journal of Anaesthesia |
| Subjects: | |
| Online Access: | https://journals.lww.com/10.4103/ija.ija_289_24 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832587245864878080 |
|---|---|
| author | Indrani Hemantkumar Ashok Kumar Swain Manjaree Mishra Swati Singh Challakere Lakshminarain Gurudatt Janampet Bekkam Giridhar |
| author_facet | Indrani Hemantkumar Ashok Kumar Swain Manjaree Mishra Swati Singh Challakere Lakshminarain Gurudatt Janampet Bekkam Giridhar |
| author_sort | Indrani Hemantkumar |
| collection | DOAJ |
| description | 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 (P > 0.05 in all four procedures). Heart rate was significantly higher in the fentanyl group in comparison to the remifentanil group during laryngeal intubation (P = 0.035), skin incision (P = 0.017), skin closure (P = 0.001), and extubation (P = 0.026). The need for vasopressor and anti-cholinergic drugs was similar between groups, and no subject required naloxone administration.
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. |
| format | Article |
| id | doaj-art-c4d9aec4c48c47c1b17191ddfb680fe9 |
| institution | Kabale University |
| issn | 0019-5049 0976-2817 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Indian Journal of Anaesthesia |
| spelling | doaj-art-c4d9aec4c48c47c1b17191ddfb680fe92025-01-24T15:13:14ZengWolters Kluwer Medknow PublicationsIndian Journal of Anaesthesia0019-50490976-28172024-11-01681198599510.4103/ija.ija_289_24Efficacy and safety of a generic remifentanil formulation versus fentanyl and Ultiva during general anaesthesia: A phase III, prospective, multi-centric, observer-blind, randomised controlled trialIndrani HemantkumarAshok Kumar SwainManjaree MishraSwati SinghChallakere Lakshminarain GurudattJanampet Bekkam GiridharBackground 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 (P > 0.05 in all four procedures). Heart rate was significantly higher in the fentanyl group in comparison to the remifentanil group during laryngeal intubation (P = 0.035), skin incision (P = 0.017), skin closure (P = 0.001), and extubation (P = 0.026). The need for vasopressor and anti-cholinergic drugs was similar between groups, and no subject required naloxone administration. 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.https://journals.lww.com/10.4103/ija.ija_289_24analgesiaconscious sedationfentanylhaemodynamicsremifentanil |
| spellingShingle | Indrani Hemantkumar Ashok Kumar Swain Manjaree Mishra Swati Singh Challakere Lakshminarain Gurudatt Janampet Bekkam Giridhar 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 Indian Journal of Anaesthesia analgesia conscious sedation fentanyl haemodynamics remifentanil |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | analgesia conscious sedation fentanyl haemodynamics remifentanil |
| url | https://journals.lww.com/10.4103/ija.ija_289_24 |
| work_keys_str_mv | AT indranihemantkumar efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial AT ashokkumarswain efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial AT manjareemishra efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial AT swatisingh efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial AT challakerelakshminaraingurudatt efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial AT janampetbekkamgiridhar efficacyandsafetyofagenericremifentanilformulationversusfentanylandultivaduringgeneralanaesthesiaaphaseiiiprospectivemulticentricobserverblindrandomisedcontrolledtrial |