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The impact of administering lidocaine intravenously prior to removing the breathing tube on recovery following breast surgery

Effects of intravenous lidocaine bolus before tracheal extubation on recovery after breast surgery – Lidocaine At The End (LATE) study: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71855856
Enrollment
73
Registered
2023-07-04
Start date
2007-07-18
Completion date
Unknown
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of the emergence after general anesthesia, prevention of bucking, cough, sore throat, and PONV for 24 hours after general anesthesia in women who underwent breast surgery Surgery

Interventions

Patients were randomized by computer-generated random numbers to receive either lidocaine or the same volume of saline (control) on the emergence from anesthesia. At the end of skin closure, volatile

Sponsors

Opca Bolnica Zadar
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Adult women 2. American Society of Anesthesiologists physical status I to II 3. Women undergoing breast tumor surgery (lumpectomy, simple mastectomy, radical or modified radical mastectomy)

Exclusion criteria

Exclusion criteria: 1. Anticipated difficult intubation 2. Multiple intubation attempts 3. History of sore throat, cough, and respiratory infections 4. Having been intubated within the last two months 5. Chronic obstructive lung disease 6. Asthma 7. Treatment with ß-blocking agents 8. Known hypersensitivity to drugs used in the study protocol 9. Obesity (body mass index >30 kg/m²) 10. The study protocol was broken 11. Conditions that arose that influenced outcomes during the surgery ( unexpected intraoperative drug allergy, severe intraoperative hypotension lasting more than three minutes, perioperative hypoxia lasting more than one minute, excessive blood loss, difficult intubation, or serious postoperative surgical complications)

Design outcomes

Primary

MeasureTime frame
Quality of the emergence measured by: 1. The number of bucking episodes before extubation 2. The number of coughs and sore throat episodes at one, three, and five minutes after extubation, 3. The number of coughs and sore throat episodes at two and 24 hours postoperatively

Secondary

MeasureTime frame
1. PONV - postoperative nausea and vomiting (retching) (incidence, number of episodes) 2. Severity of nausea evaluated with a 100-mm visual analog scale (VAS) (0=no pain to 100=maximum pain) at 2 h and 24h postoperatively 3. Postoperative pain evaluated with a 100-mm visual analog scale (VAS) at the same time points (0=no pain to 100=maximum pain)

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026