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ObeseNCT03029715

Anaesthesia for Laparoscopic Sleeve Gastrectomy

A study testing Propofol, Remifentanil and Dexmedetomidine in people with Obese, run by Menoufia University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Obese
What is being tested?
Propofol, Remifentanil and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Feb 2014to Sep 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Morbid obese scheduled for sleeve gastrectomy.

Who cannot join

  • Patients refusal and allergy to drugs used.

About this study

Official title: Comparative Study Between Inhalational Anaesthesia and Total Intravenous Anaesthesia (TIVA) With Dexmedetomidine for Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study was carried out to compare the use of inhalation anaesthesia technique using desflurane and TIVA using propofol and dexmedetomidine.

Methods: This randomized controlled trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion. Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and post-anaesthetic care unit (PACU) stay were studied for both groups.

Read the detailed description

After obtaining the ethics committee approval of El Menoufia University hospital and the informed written consent from the patients, a hundred morbidly obese patients scheduled for sleeve gastrectomy were recruited for the study. Patients with history of cardiac comorbidity, chronic obstructive lung disease, drug abuse, expected difficult intubation patients, and patients with history of allergy to the study drugs were excluded from the study. Patients from 30 to 50 years old of both sexes were randomly allocated using computerized software into two groups, fifty patients in each group. Patients in inhalation group received intra-operative inhalational anaesthetic while patients in TIVA group received TIVA for anaesthetic maintenance.

All patients received a routine premedication with oral sodium citrate 15ml [0.3 molar (1.16gm)] and intravenous (IV) 4mg ondansetron fifteen minutes before induction. Patients in both groups were connected to the routine monitoring and bispectral index (BIS) upon arrival to theatre. Anaesthesia induction for both groups was carried out by 0.5-1 mcg kg -1 remifentanil, 2-3mg kg-1 propofol, and 0.6 mg kg-1 rocuronium. Endotracheal intubation was done with the appropriate tube size.

In the inhalational group, anaesthesia was maintained by desflurane in low flow oxygen air mixture 60/40%. In the TIVA group, anaesthesia was maintained using propofol 8-12 mg kg-1 h-1 and dexmedetomidine 0.5-1ugkg-1h-1. Remifentanil infusion of 0.05-2 µg kg-¹min-¹ was administered for both groups. Muscle relaxation was maintained in both groups by rocuronium infusion at a rate of 10-12ug kg1min-1. Depth of anaesthesia was monitored by bispectral index and anaesthetics were adjusted in both groups to obtain BIS of 40 to 60 by giving boluses of 0.5ug kg-1 remifentanil. The total boluses of intra-operative remifentanil were recorded. At the end of the procedure all patients received 0.6mg atropine and sugammadex 16mg kg-1 to reverse the effect of rocuronium. Patients were extubated and transferred to the post-anaesthetic care unit (PACU).

Post-operative pain was monitored using visual analogue score (VAS) at PACU. Morphine sulphate 2 to 3 mg was given if the VAS was > 4. Intravenous paracetamol 1gm and/or ketorolac 30 mg were given eight hourly intravenously if needed (VAS ≥3). Post-operative ondansetron 4mg every eight hours was given if required.

Haemodynamics including heart rate and mean arterial blood pressure (MABP) were recorded as a baseline and every fifteen minutes intra-operatively. Recovery time from anaesthesia using Aldrete score was recorded (the time from cessation of all anesthetics until complete recovery). 10 The incidence of post-operative nausea and vomiting, post-operative analgesic requirements, and the duration of PACU stay were recorded. Post-operative pain assessment using VAS from 0 to 10, where 0 means no pain and 10 is the worst pain the patient experienced. VAS was recorded at full recovery, every 15 minutes in PACU until discharge PACU. Time of onset of post-operative bowel movement was recorded.

Statistical analysis:

Sample size calculation was calculated using Graphed Instant statistics version 3. Based on the previous, studies propofol was expected to produce a drop in the MABP after induction of anaesthesia by about 10 mmHg with a standard deviation of 15 mmHg so by choosing level of significance 0.05 and power of 90%; the calculated sample size was 48 patients so that the number of patients randomized in each group was fifty patients to ensure reliable results.

Statistical analysis was done using SPSS 19 (SPSS Inc, IBM company, Chicago,USA). The patients' sex, American society of anaesthetists (ASA) status and incidence of side effects were analyzed using the chi-square χ2-test. Other parameters were compared using student t-test. For comparisons within the same group, paired t-test was used where for comparisons between groups; unpaired t-test was used. P-value less than 0.05 was considered statistically significant.

Conditions
Obese
Being tested
Propofol, Remifentanil, Dexmedetomidine, Desflurane
Keywords
Sleeve gastrectomy, TIVA
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Also called TIVA group

    Total intravenous anaesthesia.

  • RemifentanilDrug

    Also called TIVA group and inhalation group

    Narcotics

  • DexmedetomidineDrug

    Also called TIVA group

    Total intravenous anaesthesia

  • DesfluraneDrug

    Also called Inhalation group

    Inhalation anaesthesia.

Study groups in NCT03029715
Study groupRoleWhat they receive
Intravenous anaesthesiaOtherPropofol Dexmedetomidine Remifentanil
Receives: Drug: Propofol; Drug: Remifentanil; Drug: Dexmedetomidine
Inhalation anaesthesiaOtherDesflurane Remifentanil
Receives: Drug: Remifentanil; Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analgesic Requirements.

    Total paracetamol consumption.

    Measured: Within one hour after surgery

Secondary outcomes (1)
  1. The Intra-operative Mean Arterial Blood Pressure.

    Measured: During operation and follow-up, an average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2017 (estimated)
  2. Study startFeb 2014
  3. Primary completionMar 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03029715
Sponsor's protocol ID
MenoufiaU2016/2
Status last verified
Aug 2020
First submitted
14 Jan 2017
Last updated
16 Sep 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • Elbakry AE, Sultan WE, Ibrahim E. A comparison between inhalational (Desflurane) and total intravenous anaesthesia (Propofol and dexmedetomidine) in improving postoperative recovery for morbidly obese patients undergoing laparoscopic sleeve gastrectomy: A double-blinded randomised controlled trial. J Clin Anesth. 2018 Mar;45:6-11. doi: 10.1016/j.jclinane.2017.12.001. Epub 2017 Dec 8.

    PubMed 29223575

Questions about this trial

What is this clinical trial studying?

A study testing Propofol, Remifentanil and Dexmedetomidine in people with Obese, run by Menoufia University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesic Requirements. (time frame: Within one hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03029715, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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