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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04086940
Other study ID # Ain Shams university 1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 2019
Est. completion date December 2019

Study information

Verified date November 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.


Description:

Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.

Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) I - II patients

- age between 18-59 years

- both genders

- body mass index (BMI) > 45 kg/m2

Exclusion Criteria:

- Patients with -hepatic

- renal

- cardiac

- respiratory diseases

- patients with a history of drug abuse or who were dependent on opioid drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esmolol
preventive

Locations

Country Name City State
Egypt Ramymahrose Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary intraoperative analgesic requirements amount of narcotics and anesthetics needed 6 months
Primary postoperative analgesic requirements amount of narcotics needed 6 months
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