Anaesthesia for Laparoscopic Sleeve Gastrectomy
Condition: Obese
Study type: Interventional

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. 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.
    

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.
    

Intervention name(s): Propofol; Remifentanil; Dexmedetomidine; Desflurane
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Total intravenous anaesthesia.; Narcotics; Total intravenous anaesthesia; Inhalation anaesthesia.
Other intervention name(s): TIVA group; TIVA group and inhalation group; TIVA group; Inhalation group
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Sleeve gastrectomy; TIVA