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NCT05962671 Clinical Trial

Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery

Anesthesia Clinical Trial

Official title:
Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05962671
Other study ID # 36264MS154/4/23
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date August 10, 2023
Est. completion date March 30, 2024

Study information
Verified date July 2023
Source Tanta University
Contact Samah M Marie, MBBCh
Phone +20 120 745 203
Email mohamedsamah084@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.

Description:

The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 72
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adult patients = 18 years - Admitted to the post anesthesia care unit after bariatric surgery Exclusion Criteria: • Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Opioid-sparing based anesthesia
Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
• Sevoflurane-based anesthesia
Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.

Locations
Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Early postoperative hypoventilation Early postoperative respiratory hypoventilation will be defined by any of the following parameters:
Oxygen saturation < 95% for 10 seconds. Respiratory rate < 8 breath/min. Apnea spill > 10 seconds. pain/sedation-mismatch.		 UP to 24 hours Postoperatively
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