Opioid-free general anesthesia for Transthoracic Oesophagectomy; Does it improve postoperative analgesia and other recovery criteria? A prospective randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202010907549506

Enrollment

Registered

2020-10-06

Start date

2020-07-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Anaesthesia

Interventions

opioid based anesthesia group B

opioid free anesthesia group A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients age range between 18- 64 years candidates for elective transthoracic oesophagectomy forced vital capacity (FVC) or force expiratory volume 1 (FEV1) = 60% of the predicted values.

Exclusion criteria

Exclusion criteria: Patients age below 18 years or above 64 years old History of thoracic trauma FVC or FEV1 = 60% of predicted values History of obstructive sleep apnea or need for home CPAP mask Severe hypertension Uncontrolled diabetes mellitus Severe cardiovascular, renal or hepatic diseases History of analgesic administration or intake during past 24 hours Pregnant females History of relevant drug allergy.

Design outcomes

Primary

Measure	Time frame
The primary goal of this study will be assessment of the effectiveness of OFA in transthoracic oesophagectomy in comparison with opioid-based technique (OBA) regarding the postoperative pain profile assessed by the visual analogue score (VAS) for 6 hours (0 = no pain, 1 - 3 = mild pain, 4 - 6 = moderate pain, 7 - 10 = severe pain)	—

Secondary

Measure	Time frame
Respiratory rate and oxygen saturation will be recorded immediately before and after extubation and every 10 minutes for 30 minutes postoperative then it will be recorded every hour for the next 6 hours in the ICU.;Postoperative hemodynamics including mean heart rate (bpm) and MAP (mmHg) which will be recorded from the immediate postextubation, and every hour till the next 6 hours postoperatively;The incidence of postoperative hypoxia (Spo2= 90%) to which oxygen (6-10 L) via face mask will be applied during the first 6 hours postoperative and according to response to this step the patients will be assessed clinically by (respiratory rate, Spo2, ABG) for the need of mechanical ventilation either invasive or non-invasive.;Incidence of postoperative nausea and vomiting during the first 6 hours which will be treated by granisetrone 1mg intravenous.	—

Measure

Time frame

Respiratory rate and oxygen saturation will be recorded immediately before and after extubation and every 10 minutes for 30 minutes postoperative then it will be recorded every hour for the next 6 hours in the ICU.;Postoperative hemodynamics including mean heart rate (bpm) and MAP (mmHg) which will be recorded from the immediate postextubation, and every hour till the next 6 hours postoperatively;The incidence of postoperative hypoxia (Spo2= 90%) to which oxygen (6-10 L) via face mask will be applied during the first 6 hours postoperative and according to response to this step the patients will be assessed clinically by (respiratory rate, Spo2, ABG) for the need of mechanical ventilation either invasive or non-invasive.;Incidence of postoperative nausea and vomiting during the first 6 hours which will be treated by granisetrone 1mg intravenous.

—

Countries

Egypt

Contacts

Public ContactWael Algharbawy

Lecturer of anesthesia intensive care and pain faculty of medicine Ain Shams university

gharabawy76@yahoo.com01096973949

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026