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NCT Number: NCT05951686

The Effect of Anesthetic Methods on Gastrointestinal Motility

The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis.

Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages.

Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.

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Key information

Conditions

Anesthesia Total Intravenous Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bozyaka Training and Research Hospital

Izmir, Bozyaka, Turkey (Türkiye)

About this study

Aim of this study is to evaluate the effect of two anesthetic methods on gastric motility during laparoscopic sleeve gastrectomy. Patients scheduled for laparoscopic sleeve gastrectomy with American Society of Anesthesiology (ASA) physical status II and III will enrolled into two groups. Computer based randomization will be used for the group selection. Patients will be monitored with standard monitorization (peripheral oxygen saturation, non-invasive blood pressure, 3-lead electrocardiography and patient state index (PSI)). Preoxygenation will be performed via a face mask with 6 L/min oxygen for 5 minutes. All patients will receive intravenous 2 mg/kg propofol, 0.25 mcg/kg/min remifentanil for anesthesia induction. Rocuronium bromide will be used intravenously with a dose of 0.6 mg/kg for muscle relaxation. Endotracheal intubation will be performed. In Group 1, inhalation anesthetic, desflurane and in Group 2, propofol infusion will be used with a 2 L/ min fresh gas flow as a mixture of 50 %- 50 % oxygen- medical air for maintenance of general anesthesia. Remifentanil infusion with a dose of 0.05-2 mcg/kg/min will be used in both groups during anesthesia maintenance. Anesthesia depth will be monitored with EEG monitorization where a score of 25-50 will be achieved in PSI . End-tidal carbon dioxide pressure will be kept between 35 and 45 mmHg. End-expiratory positive pressure will be set to 8 mmHg and intraabdominal pressure will be set to 12 mmHg. The surgeon will assess the gastric motility during anastomosis. The peristalsis during 1 minute period will be counted. 1 gram paracetamol and 1 mg/kg tramadol will be given intravenously for pain management. Sugammadex will be used for the reversal of neuromuscular blockade. Postoperative nause and vomiting, the time of first fart will be noted. Surgeon's satisfaction during anastomosis will be assessed with 5 points Likert Scale. Data will be statistically analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-60 ages
  • ASA II-III
  • Patients scheduled for elective laparoscopic sleeve gastrectomy
  • Body mass index 35 kg m2 and over

Exclusion criteria

  • Hepatic disease
  • Kidney disease
  • Congestive heart disease
  • Diabetes mellitus
  • Neurological deficit
  • Psychiatric disease
  • Pregnancy
  • Delayed gastric empting
  • Previous bariatric surgery
  • Patient's refusal
  • Open surgery

Treatment and study plan

Desflurane

Drug

In inhalation group, desflurane will be used for general anesthesia maintenance under the screening with Patient State Index (PSI) between a score of 25-50. Remifentanil infusion is used with desflurane with a dose of 0.05-2 mcg/ kg/ min according to PSI . Fresh gas flow is used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.

Other names: suprane

Remifentanil infusion

Drug

Remifentanil infusion will be used with a dose of 0.05-2 mcg/ kg/ min under the screening with Patient State Index (PSI) between a score of 25-50 in both groups.

Other names: ultiva

Fresh gas

Other

Fresh gas flow will be used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.

Propofol infusion

Drug

Propofol infusion will be used for general anesthesia maintenance with a dose of under the screening of Patient State Index (PSI) between a score of 25-50 in group tiva.

Other names: propofol 2%

Primary outcomes

  1. Gastrointestinal motility

    Time frame: during surgery

    Gastrointestinal motility is the number of peristalsis during a one minute period. The surgeon will be asked to count the number of peristalsis during surgical anastomosis in a one minute period.

Secondary outcomes

  1. Fart

    Time frame: up to 24 hours after surgery

    The time of first fart

  2. Nause and vomiting

    Time frame: up to 24 hours after surgery

    Incidence of postoperative nause and vomiting

  3. Satisfaction of surgeon

    Time frame: during surgery

    Ease of anastomosis and satisfaction of surgeon will be measured with 5 point Likert Scale as 1: very dissatisfied, 2:dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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