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

NCT ID: NCT05962671

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia Hypoventilation Opioid Use Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Opioid-sparing based anesthesia

Intervention Type DRUG

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%.

Group Type ACTIVE_COMPARATOR

Sevoflurane-based anesthesia

Intervention Type DRUG

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%.

Interventions

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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.

Intervention Type DRUG

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%.

Intervention Type DRUG

Other Intervention Names

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Opioid Sevoflurane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Samah Mohamed Marie

Doctor resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Samah M Marie, MBBCh

Role: CONTACT

+20 120 745 203

Facility Contacts

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Samah M Marie, MBBCH

Role: primary

+20 120 745 203

Other Identifiers

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36264MS154/4/23

Identifier Type: -

Identifier Source: org_study_id

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